RESUMO
PURPOSE: The purpose of this study was to evaluate the value of 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) for early prediction of standard anatomic response and survival outcomes in patients with metastatic colorectal cancer (mCRC) receiving Regorafenib. METHODS: Sixty-eight patients with mCRC refractory to standard cytotoxic chemotherapy were enrolled and received Regorafenib (160 mg/day on days 1-21, following a 7-day break). Standard anatomical response was evaluated every 8 weeks. Both scans were performed before and on day 21 of Regorafenib. RESULTS: Of the 61 patients included in per-protocol analysis, complete response was not observed, but partial response was observed in 8.2% (n = 5), stable disease in 67.2% (n = 41), and progressive disease in 24.6% (n = 15). The objective response rate was 8.2% and disease control rate 75.4%. Five responders (8.2%) and 13 non-responders (21.3%) met the CT and 18F-FLT PET/CT criteria (maximum standardized uptake value decrease ≥ 10.6% for responders). Forty-three (70.5%) exhibited discordant responses on CT and 18F-FLT PET/CT (McNemar test, P < 0.001). At a median follow-up of 8.9 months, median progression-free survival (PFS) and median overall survival (OS) were 3.6 months (95% confidence interval [CI], 3.34-3.80 months) and 8.5 months (95% CI, 6.95-10.10 months), respectively. Comparison of PFS and OS according to 18F-FLT PET/CT response revealed slightly longer PFS (P = 0.015) in responders, but the correlation with OS was not significant. The PET Response Criteria in Solid Tumours (PERCIST) of 18F-FDG PET/CT revealed differences in PFS and OS between partial metabolic response (PMR) and non-PMR (P = 0.048 and P = 0.014, respectively), and between progressive metabolic disease (PMD) and non-PMD (P = 0.189 and P = 0.007, respectively). CONCLUSIONS: Survival outcome was significantly associated with PERCIST using 18F-FDG PET/CT but the change of 18F-FLT uptake was only slightly associated with PFS. 18F-FDG PET/CT can be used as imaging biomarker to predict clinical outcomes early in patients with mCRC receiving Regorafenib.
Assuntos
Antineoplásicos/uso terapêutico , Neoplasias Colorretais/diagnóstico por imagem , Didesoxinucleosídeos/efeitos adversos , Compostos de Fenilureia/uso terapêutico , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/normas , Piridinas/uso terapêutico , Compostos Radiofarmacêuticos/efeitos adversos , Adulto , Idoso , Ensaios Clínicos como Assunto , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Didesoxinucleosídeos/normas , Feminino , Fluordesoxiglucose F18/efeitos adversos , Fluordesoxiglucose F18/normas , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Valor Preditivo dos TestesRESUMO
PURPOSE: (18)F-Labelled fluorodeoxyglucose (FDG) can detect early changes in tumour metabolism and may be a useful quantitative imaging biomarker (QIB) for prediction of disease stabilization, response and duration of progression-free survival (PFS). Standardization of imaging procedures is a prerequisite, especially in multicentre clinical trials. In this study we reviewed the quality of FDG scans and compliance with the imaging guideline (IG) in a phase III clinical trial. METHODS: Forty-four cancer patients were enroled in an imaging sub-study of a randomized international multicentre trial. FDG scan had to be performed at baseline and 10-14 days after treatment start. The image transmittal forms (ITFs) and Digital Imaging and Communications in Medicine (DICOM) [1] standard headers were analysed for compliance with the IG. Mean liver standardized uptake values (LSUVmean) were measured as recommended by positron emission tomography (PET) Response Criteria in Solid Tumors 1.0 (PERCIST) [2]. RESULTS: Of 88 scans, 81 were received (44 patients); 36 were properly anonymized; 77/81 serum glucose values submitted, all but one within the IG. In 35/44 patients both scans were of sufficient visual quality. In 22/70 ITFs the reported UT differed by >1 min from the DICOM headers (max. difference 1 h 4 min). Based on the DICOM, UT compliance for both scans was 31.4%. LSUVmean was fairly constant for the 11 patients with UT compliance: 2.30 ± 0.33 at baseline and 2.27 ± 0.48 at follow-up (FU). Variability substantially increased for the subjects with unacceptable UT (11 patients): 2.27 ± 1.04 at baseline and 2.18 ± 0.83 at FU. CONCLUSION: The high attrition number of patients due to low compliance with the IG compromised the quantitative assessment of the predictive value for early response monitoring. This emphasizes the need for better regulated procedures in imaging departments, which may be achieved by education of involved personnel or efforts towards regulations. LSUVmean could be monitored to assess quality and compliance in an FDG PET/CT study.
Assuntos
Fluordesoxiglucose F18/normas , Guias como Assunto , Tomografia por Emissão de Pósitrons/normas , Compostos Radiofarmacêuticos/normas , Sarcoma/diagnóstico por imagem , Neoplasias de Tecidos Moles/diagnóstico por imagem , Ensaios Clínicos Fase III como Assunto , Humanos , Estudos Multicêntricos como Assunto , Tomografia por Emissão de Pósitrons/métodos , Controle de Qualidade , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: PET images are affected by scanner model, reconstruction conditions, injected dose, scan duration, patient health status and FDG radiopharmaceutical supply systems. The present study compares images of 40 patients using commercial and in-house FDG systems with one PET scanner (Aquiduo). METHODS: The PET images were evaluated using the physical indexes of NECpatient, NECdensity and SNRliver proposed by the Japanese guidelines for oncological FDG-PET/CT, and by visual assessment. RESULTS: There were no significant differences in the physical indexes between PET images generated using commercial and in-house FDG. The physical indexes were also acceptable according to the recommended Japanese guidelines. NECdensity was higher when a higher dose/body weight of commercial FDG was injected (correlation coefficient: r=0.576, p<0.001) and lower when BMI was lower and in-house FDG was injected (r=-0.786, p<0.0001). These results suggest that scan duration should be increased if the injected dose of commercial FDG/body weight is <5.5 MBq/kg, and if individuals with BMI >21.4 kg/m(2) are injected with in-house FDG. CONCLUSIONS: Scan duration should be varied depending on FDG supply systems to ensure more accurate image quality and quantitative values during evaluations of response to therapy and prognostic prediction.
Assuntos
Fluordesoxiglucose F18/normas , Tomografia por Emissão de Pósitrons , Compostos Radiofarmacêuticos/normas , Tomografia Computadorizada por Raios X , HumanosRESUMO
OBJECTIVE: A workgroup commissioned by the Alzheimer's Association (AA) and the National Institute on Aging (NIA) recently published research criteria for preclinical Alzheimer disease (AD). We performed a preliminary assessment of these guidelines. METHODS: We employed Pittsburgh compound B positron emission tomography (PET) imaging as our biomarker of cerebral amyloidosis, and (18) fluorodeoxyglucose PET imaging and hippocampal volume as biomarkers of neurodegeneration. A group of 42 clinically diagnosed AD subjects was used to create imaging biomarker cutpoints. A group of 450 cognitively normal (CN) subjects from a population-based sample was used to develop cognitive cutpoints and to assess population frequencies of the different preclinical AD stages using different cutpoint criteria. RESULTS: The new criteria subdivide the preclinical phase of AD into stages 1 to 3. To classify our CN subjects, 2 additional categories were needed. Stage 0 denotes subjects with normal AD biomarkers and no evidence of subtle cognitive impairment. Suspected non-AD pathophysiology (SNAP) denotes subjects with normal amyloid PET imaging, but abnormal neurodegeneration biomarker studies. At fixed cutpoints corresponding to 90% sensitivity for diagnosing AD and the 10th percentile of CN cognitive scores, 43% of our sample was classified as stage 0, 16% stage 1, 12 % stage 2, 3% stage 3, and 23% SNAP. INTERPRETATION: This cross-sectional evaluation of the NIA-AA criteria for preclinical AD indicates that the 1-3 staging criteria coupled with stage 0 and SNAP categories classify 97% of CN subjects from a population-based sample, leaving only 3% unclassified. Future longitudinal validation of the criteria will be important.
Assuntos
Doença de Alzheimer/diagnóstico , Encéfalo/diagnóstico por imagem , Transtornos Cognitivos/diagnóstico , National Institute on Aging (U.S.)/normas , Idoso , Idoso de 80 Anos ou mais , Compostos de Anilina/normas , Biomarcadores , Progressão da Doença , Feminino , Fluordesoxiglucose F18/normas , Humanos , Estudos Longitudinais , Masculino , Entrevista Psiquiátrica Padronizada , Testes Neuropsicológicos , Tomografia por Emissão de Pósitrons , Tiazóis/normas , Estados UnidosRESUMO
PURPOSE: We retrospectively compared the maximum standard uptake value (SUVmax) of FDG PET in four different sites to evaluate whether a common diagnostic SUVmax threshold may exist in these tumor locations. We further postulate that the SUVmax thresholds are higher in thoracic lesions than in extrathoracic lesions. MATERIAL AND METHODS: N = 143 patients in four subgroups underwent a FDG PET/CT: a) 42 patients for solitary pulmonary nodules (SPNs) characterization with b) respective mediastinal lymph nodes (LNs), c) 65 patients for LN staging of head and neck cancer, and d) 36 cancer patients diagnosed with adrenal lesions. Receiver operating characteristics of SUVmax values were evaluated. RESULTS: The SUVmax were statistically significantly greater in malignant than in benign lesions. For SPNs and mediastinal LNs, a SUVmax > 3.6 each resulted in a sensitivity of 81% and 87%, and a specificity of 94% and 89%. For cervical LNs and adrenal glands, a SUVmax > 2.2 each showed a sensitivity of 98% and 100%, and a specificity of 83% and 93%. CONCLUSION: A common SUVmax threshold did not exist in the four studied subgroups. The variable FDG uptake in SPNs and mediastinal LNs are associated with the high prevalence of inflammation/infection within the chest. Similar SUVmax thresholds however may exist for extrathoracic regions where the prevalence of inflammation/infection is low.
Assuntos
Fluordesoxiglucose F18/farmacocinética , Fluordesoxiglucose F18/normas , Tomografia por Emissão de Pósitrons , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/diagnóstico por imagem , Carcinoma Pulmonar de Células não Pequenas/metabolismo , Carcinoma Pulmonar de Células não Pequenas/patologia , Feminino , Neoplasias de Cabeça e Pescoço/diagnóstico por imagem , Neoplasias de Cabeça e Pescoço/metabolismo , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/metabolismo , Neoplasias Pulmonares/patologia , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Tomografia por Emissão de Pósitrons/métodos , Tomografia por Emissão de Pósitrons/normas , Padrões de Referência , Estudos Retrospectivos , Sensibilidade e Especificidade , Nódulo Pulmonar Solitário/diagnóstico por imagem , Nódulo Pulmonar Solitário/metabolismo , Tomografia Computadorizada por Raios X/métodos , Tomografia Computadorizada por Raios X/normasRESUMO
OBJECTIVES: The objectives of this study were to assess the maximum standardized uptake value (SUVmax) of F-fluorodeoxyglucose (F-FDG) by a primary tumor of endometrial cancer with the use of positron emission tomography/computed tomography (PET/CT) and to assess its association with the clinical importance of the disease. METHODS: F-fluorodeoxyglucose PET/CT scan was performed on 44 participants within 2 weeks before surgery. F-fluorodeoxyglucose uptake was quantified by calculating the SUVmax. The distribution of cases that scored positive for each of the biological parameters examined was correlated with the SUVmax of the F-FDG PET/CT and the glucose transporter-1 expression status obtained by immunohistochemistry. RESULTS: The mean SUVmax of the primary endometrial cancer tumors was 17.6 (range, 3.04-34.74). There were significant correlations between the SUVmax of the primary tumor and the International Federation of Gynecology and Obstetrics (FIGO) grade (P < 0.001), maximum tumor size (P < 0.001), and glucose transporter-1 expression (P < 0.001). Furthermore, multivariate analysis showed that the FIGO grade was most significantly identified as a relation factor of SUVmax (> or =17.6) for endometrial cancer (P = 0.017). The present findings indicate that a significant relationship was seen between the SUVmax and the FIGO grade in endometrial cancer. CONCLUSION: We propose that the primary tumor's SUVmax obtained from F-FDG PET/CT may be associated with aggressive biological characteristics in endometrial cancer.
Assuntos
Carcinoma Endometrioide/diagnóstico por imagem , Neoplasias do Endométrio/diagnóstico por imagem , Fluordesoxiglucose F18/farmacocinética , Estadiamento de Neoplasias/métodos , Tomografia por Emissão de Pósitrons/normas , Idoso , Idoso de 80 Anos ou mais , Biomarcadores Tumorais/metabolismo , Carcinoma Endometrioide/metabolismo , Carcinoma Endometrioide/patologia , Neoplasias do Endométrio/metabolismo , Neoplasias do Endométrio/patologia , Feminino , Fluordesoxiglucose F18/normas , Transportador de Glucose Tipo 1/metabolismo , Humanos , Imuno-Histoquímica , Pessoa de Meia-Idade , Padrões de Referência , Carga Tumoral/fisiologiaRESUMO
Radiopharmaceuticals play an important role in modern nuclear medicine, and 18F-FDG (2-[18F] fluoro-2-deoxy-D-glucose) is the most frequently used in imaging examinations today. The pyrogen test represents an important parameter for the quality of radiopharmaceuticals since most of them, 18F-FDG included, are injectable solutions. However, the standard test proposed by the U.S. Pharmacopeia using limulus amebocyte lysates takes too long (about 1 h). An alternative test is the Portable Test System, which takes no more than 15 min. In order to compare both tests, 10 batches of 18F-FDG produced in the Nuclear Engineering Institute, Rio de Janeiro, Brazil, were analyzed. The results showed that in 40% of the samples analyzed, different results were found. From the total analyzed, 20% showed totally diverging results, and 80% demonstrated partial similarity. These differences have a great impact in the choice of the test used for radiopharmaceutical injectable solutions and the importance of validation tests before the implementation in the daily routine.
Assuntos
Fluordesoxiglucose F18/normas , Teste do Limulus , Farmacopeias como Assunto , Pirogênios/análise , Compostos Radiofarmacêuticos/normasRESUMO
PURPOSE: To study the role of 18FDG- PET (Flourodeoxyglucose positron emission tomography) in a) determining the extent of cranial and extra-cranial disease and b) diagnosis as well as prognosis of CNS TB (central nervous system tuberculosis) including TBM (tuberculous meningitis). PATIENTS AND METHODS: This prospective observational study (nâ¯=â¯70) was carried out at a tertiary care institute in Northern India from 1.1.2017 to 30.6.2018. Diagnosis of TBM was made according to modified Ahuja's criteria. All patients were evaluated in detail and treated as per standard guidelines. All patients underwent 18FDG-PET scanning of brain and whole body at baseline. RESULTS: Mean age was 35.2⯱â¯14.8â¯years. There were 37 men. Majority of patients (nâ¯=â¯47; 67.1%) were below 40â¯years of age. 43 (61.4%) patients were in stage II TBM. The mean duration of illness was 77⯱â¯101.9â¯days. Majority of patients presented with fever (94.3%), headache (90%) and vomiting (84.3%). MRI was abnormal at baseline in 67 (95.7%) of patients, most common abnormalities being meningeal enhancement (68.6%) and tuberculomas (57.1%). PET was abnormal in 66 (95.7%) of patients. All these patients had either lung lesions (nâ¯=â¯62, 88.6%) or lymphadenopathy (nâ¯=â¯61; 87.1%). 18FDG-PET revealed evidence of brain lesions in 52 (74.3%) patients. It revealed vertebral involvement in 19 (27.1%) and genitourinary lesions in 9 (12.9%) patients. PET evidence of lymphadenopathy correlated significantly (pâ¯=â¯.04) with good outcome in CNS TB. Conclusion 18FDG-PET does seem to have a promising role in initial evaluation of patients with CNS TB.
Assuntos
Fluordesoxiglucose F18 , Tomografia por Emissão de Pósitrons/métodos , Centros de Atenção Terciária , Tuberculose Meníngea/diagnóstico por imagem , Tuberculose Meníngea/metabolismo , Adulto , Feminino , Fluordesoxiglucose F18/metabolismo , Fluordesoxiglucose F18/normas , Humanos , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Tomografia por Emissão de Pósitrons/normas , Estudos Prospectivos , Centros de Atenção Terciária/normas , Tuberculose Meníngea/epidemiologia , Adulto JovemRESUMO
Cervical cancer recently has become more common among younger women in Japan. Diagnosing early-stage cancer is straightforward using cervical cytodiagnosis and histological diagnosis. However, postmenopausal endophytic cervical cancer and skip lesions in cervical adenocarcinoma are difficult to detect. We compared the maximum standardized uptake value (SUVmax) of 18F-fluorodeoxy-glucose positron emission tomography/computed tomography (PET/CT) for primary staging of cervical cancer and evaluated the relationship of the imaging findings to prognosis.This was a retrospective study of 38 patients with cervical cancer who underwent PET/CT. Patients were grouped according to disease stage, and the mean SUVmax, overall survival, and progression-free survival (PFS) were evaluated.The mean SUVmax was significantly different between patients with stage ≤I and ≥II diseases among those with squamous (Pâ>â.001) and glandular (Pâ=â.023) lesions. With an SUVmax of receiver operating characteristic curves as the optimal cutoff value, the log-rank test for PFS revealed a statistically significant difference between the 2 disease stages (Pâ=â.020 and Pâ=â.016, respectively).SUVmax is useful to differentiate between stage ≤I and ≥II cervical cancer. SUVmax may be useful for the prognostic evaluation of disease recurrence in patients with cervical cancer.
Assuntos
Fluordesoxiglucose F18/normas , Estadiamento de Neoplasias/normas , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/normas , Compostos Radiofarmacêuticos/normas , Neoplasias do Colo do Útero/diagnóstico por imagem , Adulto , Idoso , Feminino , Fluordesoxiglucose F18/farmacocinética , Humanos , Pessoa de Meia-Idade , Prognóstico , Curva ROC , Compostos Radiofarmacêuticos/farmacocinética , Padrões de Referência , Estudos RetrospectivosRESUMO
Delayed 18F-2-fluoro-2-deoxy-D-glucose (F-FDG) positron emission tomography (PET) imaging has been associated with improved diagnostic yield in several malignancies; however, data on the use of delayed imaging in patients with hepatocellular carcinoma (HCC) is scarce. This study aimed to examine tumoral and background standardized uptake value (SUV) alterations in dual-phase F-FDG PET/computed tomography (CT) imaging.Fifty-two HCC cases underwent dual-time-point F-FDG PET/CT examination where early and delayed images were obtained. The maximum and mean SUVs (SUVmax and SUVmean) of the tumor were determined for both time points. Similarly, the average SUVmean were also determined for background (liver, soft tissue, and spleen). Changes in tumoral and background SUV between early and delayed images were examined.The mean age was 62.0â±â12.9 years (range, 20-88 years) and the majority of the patients were men (86.5%). Tumor SUVs, both tumor SUVmean and tumor SUVmax, significantly increased at delayed images when compared to early images. In contrast, the average SUVmean for the liver, soft tissue, and spleen significantly decreased at delayed images.A significant increase in tumor SUV in delayed images in contrast to a significant decrease in background SUVs suggests that delayed images in HCC may contribute to diagnostic performance through a potential increase in the contrast between the tumor and background. However, further studies with larger sample sizes including patients with benign lesions and different grades of the disease are warranted to better elucidate the diagnostic contribution as well as the association of delayed imaging values with prognosis.
Assuntos
Carcinoma Hepatocelular/diagnóstico por imagem , Fluordesoxiglucose F18/normas , Neoplasias Hepáticas/diagnóstico por imagem , Tomografia por Emissão de Pósitrons/normas , Compostos Radiofarmacêuticos/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Fígado/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Tomografia por Emissão de Pósitrons/métodos , Padrões de Referência , Baço/diagnóstico por imagem , Adulto JovemRESUMO
OBJECTIVE: The aim of this study was to assess the physiological uptake of 18F-fluoro-2-deoxyglucose (FDG) by an apparently normal testis with combined positron emission tomography-computed tomography (PET/CT) and its correlation with age, blood glucose level, and testicular volume. METHODS: The testicular uptake of 18F-FDG, expressed as the standardized uptake value (SUV), was measured on PET/CT images in 203 men. The correlation between SUV and age, blood glucose level, and testicular volume was assessed. RESULTS: The SUV in the total of 406 testes was 2.44 +/- 0.45 (range 1.23-3.85). The SUV was 2.81 +/- 0.43 (2.28-3.85) for 30-39 years (n = 12), 2.63 +/- 0.45 (1.77-3.75) for 40-49 years (n = 64), 2.46 +/- 0.35 (1.44-3.15) for 50-59 years (n = 82), 2.51 +/- 0.41 (1.50-3.46) for 60-69 years (n = 86), 2.43 +/- 0.47 (1.42-3.29) for 70-79 years (n = 86), and 2.18 +/- 0.45 (1.23-3.03) for 80-89 years (n = 76). When we calculated the mean SUV of bilateral testes in each patient, there were significant statistical differences between those in the age group of 30-39 years and 80-89 years, 40-49 years and 80-89 years, and 50-60 years and 80-89 years, when using an unpaired test with Bonferroni correction. The laterality index (|L - R|/(L + R) x 2) in 203 men was 0.066 +/- 0.067 (0-0.522). There was a mild correlation between the mean SUV and age (r = -0.284, P < 0.001) as well as between the mean SUV and mean volume (r = +0.368, P < 0.001). There was no correlation between the mean SUV and glucose blood level (r = -0.065, P = 0.358). CONCLUSIONS: Some uptake of FDG is observed in the normal testis and declines slightly with age. Physiological FDG uptake in the testis should not be confused with pathological accumulation.
Assuntos
Fluordesoxiglucose F18/farmacocinética , Fluordesoxiglucose F18/normas , Tomografia por Emissão de Pósitrons , Testículo/metabolismo , Tomografia Computadorizada por Raios X , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Glicemia/metabolismo , Humanos , Interpretação de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Compostos Radiofarmacêuticos/farmacocinética , Compostos Radiofarmacêuticos/normas , Técnica de Subtração , Testículo/anatomia & histologiaRESUMO
BACKGROUND: Focal colorectal uptake in (18)FDG-PET/CT may be associated with a malignancy and can be quantified. This provides the basis for an automatic trigger threshold above which cases are flagged for colonoscopic evaluation and below which for individual assessment. PURPOSE: To determine the lowest maximum standard uptake (SUVmax) in colorectal cancer that could be used as a threshold to trigger endoscopic evaluation and to evaluate whether the SUVmax needs to be further normalised to a priori known extrinsic factors. METHODS: The SUVmax was measured in 54 colorectal carcinomas and correlated with gender, age, blood glucose level, injected activity, body mass index and time to scan using t test or correlation coefficients (Pearson or Spearman, according to distribution). RESULTS: There was no correlation between SUVmax and any of the extrinsic factors mentioned above. The lowest SUVmax value was 5 [mean ± SD (range): 11.1 ± 4.8 (5.0-24.6)]. CONCLUSION: In contrast to most other screening techniques, semi-automation in colorectal screening seems possible with PET/CT. This opens the door for further study into the feasibility of automated screening. Independent from extrinsic factors, an SUVmax ≥5.0 in a focal colorectal uptake in (18)FDG-PET/CT should automatically trigger for endoscopic evaluation, if not contraindicated. Cases with SUVmax <5 should be assessed individually before referral for endoscopy. Thus, more interpretation time could be spent on those cases with a lower uptake and more ambiguous diagnosis.
Assuntos
Neoplasias Colorretais/diagnóstico , Fluordesoxiglucose F18/farmacocinética , Tomografia por Emissão de Pósitrons/métodos , Tomografia Computadorizada por Raios X/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Colo/diagnóstico por imagem , Colo/metabolismo , Colonoscopia/métodos , Neoplasias Colorretais/diagnóstico por imagem , Detecção Precoce de Câncer/métodos , Feminino , Fluordesoxiglucose F18/normas , Humanos , Masculino , Pessoa de Meia-Idade , Imagem Multimodal/métodos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
UNLABELLED: The concentration of (18)F-FDG in the gastroesophageal junction (GEJ) and gastric antrum (GA) varies significantly from patient to patient. To document the reference range of uptake in patients, we reviewed the (18)F-FDG PET scans of patients with no documented gastroesophageal disease. METHODS: The medical records of patients undergoing PET/CT were reviewed. Patients with known gastric, pancreatic, or liver pathology were excluded. The peak standardized uptake value (SUV) for the GEJ and GA were measured in the remaining patients. The clinical record was also reviewed for gastroesophageal reflux disease (GERD) and previous chemotherapy. RESULTS: A total of 763 patients met the inclusion criteria (388 male and 375 female; mean age +/- SD, 57.4 +/- 17 y; range, 15-95 y). Images were recorded 68.2 +/- 11.8 min after injection of 558.7 +/- 35.1 MBq of (18)F-FDG. PET/CT was performed on a Discovery LS scanner for 373 patients and on a Biograph scanner for 390. The maximum SUV was less than 4 in 94.4% of patients. GEJ SUV measurements on the Discovery LS and on the Biograph did not significantly differ. During the 6 mo before the scan, 515 patients received no antineoplastic chemotherapy. Of the remaining 248, 137 received chemotherapy within 1 mo before the scan; 65, between 1 and 3 mo before the scan; and 46, between 3 and 6 mo before the scan. No significant differences were found between groups. GERD was documented in the records of 75 patients. Only 58 of these patients were treated with an antacid regimen. In 552 patients, GERD was not known to be present nor was antacid treatment used. An additional 136 patients had antacid treatment without specified gastric symptomatology. Patients with a history of GERD had a slightly higher but not statistically significant SUV peak in the stomach and particularly in the GEJ, except when compared with the group without associated antacid treatment (P = 0.049). CONCLUSION: In patients without a specific history of esophagogastric disease, a gastroesophageal maximum SUV less than 4 is usually not associated with gastroesophageal neoplasia.
Assuntos
Fluordesoxiglucose F18/farmacocinética , Mucosa Gástrica/metabolismo , Tomografia por Emissão de Pósitrons/métodos , Tomografia por Emissão de Pósitrons/normas , Valores de Referência , Estômago/diagnóstico por imagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Fluordesoxiglucose F18/normas , Humanos , Masculino , Pessoa de Meia-Idade , New York , Compostos Radiofarmacêuticos/farmacocinética , Compostos Radiofarmacêuticos/normas , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
UNLABELLED: For the purpose of implementing steam sterilization of 2-[18F]FDG (FDG) in the final container into routine production, we have validated and established a fully automated dispensing and sterilization system, thereby considerably reducing the radiation burden to the personnel. METHODS: The commercially available system combines aseptic dispensing of the product solution under a miniaturized laminar flow unit with subsequent steam sterilization, realized by heating of the product in the final containers by an autoclave included in the dispensing unit, thus incorporating current pharmaceutical manufacturing standards for the production of parental radiopharmaceuticals. The efficiency of the used sterilization cycle, the stability of FDG under the conditions of sterilization and the stability of the final product towards radiolysis was investigated with respect to various pH-formulations. RESULTS: The system was found to be fully valid for filling of vials in a laminar flow class A (US-class 100) environment and for sterilization of FDG in the final container. The pH for sterilizing FDG solutions must be slightly acidic to avoid decomposition. A pH of 5.5 appears to be optimal and gives FDG of very high radiochemical purity (approximately 99%). In addition, radiolysis of FDG in solutions of high activity concentration was significantly lower at pH 5.5 than at neutral pH. CONCLUSION: Terminal sterilization enables the production of FDG in full compliance with GMP-regulations even in Class C or D (US class 10,000 or 100,000) laboratories.
Assuntos
Fluordesoxiglucose F18/administração & dosagem , Compostos Radiofarmacêuticos/administração & dosagem , Esterilização/métodos , Fluordesoxiglucose F18/normas , Humanos , Concentração de Íons de Hidrogênio , Tomografia por Emissão de Pósitrons/métodos , Tomografia por Emissão de Pósitrons/normas , Compostos Radiofarmacêuticos/normas , Vapor , Esterilização/instrumentaçãoRESUMO
The quality assurance (QA) requirements (i.e., test procedure, acceptance criteria, and testing schedule) for fludeoxyglucose (18)F ((18)F-FDG) injection listed in the U.S. Pharmacopeia (USP); the draft Chemistry, Manufacturing, and Controls (CMC) issued by the U.S. Food and Drug Administration (FDA); and the European Pharmacopeia (EP) were compared. The FDA Modernization Act of 1997 requires that the QA of compounded PET drug products be in compliance with the PET compounding standards and official monographs included in the USP. However, the "sunset" clause of the PET section within the FDA Modernization Act of 1997 stipulates that all PET drug products, in due course, must meet the requirements for drug approval procedures and current good manufacturing practice, and the FDA has issued a draft CMC that includes QA specifications for (18)F-FDG injection. The purpose of this article is to discuss the pros and cons of each of the QA tests stated in the USP, CMC, and EP and to propose a practical testing method for each required test, thereby helping end users to ensure the quality of the (18)F-FDG injection product. It is hoped that this article will stimulate further cooperation among various countries worldwide in the development of a set of harmonized and sensible QA standards for all PET drug products.
Assuntos
Fluordesoxiglucose F18/normas , Compostos Radiofarmacêuticos/normas , Composição de Medicamentos/normas , Europa (Continente) , Injeções , Farmacopeias como Assunto/normas , Controle de Qualidade , Estados Unidos , United States Food and Drug AdministrationRESUMO
Recycling of [(18)O]water for [(18)F]fluoride production can be accomplished with reliable results. We have developed sensitive, robust, and rapid analyses of impurities in [(18)O]water. Anions were quantitated by capillary electrophoresis and organic residuals were quantitated by gas chromatography using methods with excellent reproducibility and linearity. Kryptofix 222 (K-222) was quantitated by a sensitive LC-MS-MS technique. Isotopic composition was determined by GC-MS with satisfactory accuracy and precision. These methods were employed to evaluate recovered [(18)O]water purified by a novel electrolysis method. 2-[(18)F]FDG yields using purified [(18)O]water with very low levels of impurities are indistinguishable from newly purchased [(18)O]water. High (> 300 ppm) carbonate concentration reduces the fluoride trapping efficiency of QMA. The analyses of anions, organics, and isotopic enrichment were applied routinely for quality control of [(18)O]water to predict a satisfactory outcome of 2-[(18)F]FDG production.
Assuntos
Cromatografia Gasosa/métodos , Eletroforese Capilar/métodos , Fluordesoxiglucose F18/síntese química , Fluordesoxiglucose F18/isolamento & purificação , Isótopos de Oxigênio/química , Isótopos de Oxigênio/isolamento & purificação , Purificação da Água/métodos , Água/química , Conservação dos Recursos Naturais/métodos , Estabilidade de Medicamentos , Fluordesoxiglucose F18/normas , Isótopos de Oxigênio/normas , Controle de Qualidade , Compostos Radiofarmacêuticos/química , Compostos Radiofarmacêuticos/isolamento & purificação , Compostos Radiofarmacêuticos/normas , Água/análise , Água/normas , Purificação da Água/normasRESUMO
A method compatible with radioactive samples, capable of detecting trace volatile components in a sample volume of ca. 1cm(3) of 2-[18F]-fluoro-2-deoxy-D-glucose solution is described. The approach, based on solid phase micro-extraction gas chromatography-mass spectrometry with a carboxen/polydimethylsiloxane based fibre, was optimised with respect to extraction time (10 min), extraction temperature (60 degrees C) and phase volume ratio (1). The analysis time, including extraction, was less than 20 min with linear responses for acetonitrile and ethanol over the ranges: 0.09-80 microg cm(-3) (22 degrees C, acetonitrile) and 0.78-79 microg cm(-3) (22 degrees C, ethanol). The detection limits were estimated to be ca. 0.78 microg cm(-3) for ethanol and 0.09 microg cm(-3) for acetonitrile. Stability studies indicated analyte losses of up to 75% over 24h and analysis of aged 2-[18F]FDG samples showed that levels of ethanol and acetonitrile were not less than 100 microg cm(-3), indicative of levels substantially greater than this in the original infusions given to human subjects.
Assuntos
Contaminação de Medicamentos/prevenção & controle , Fluordesoxiglucose F18/análise , Cromatografia Gasosa-Espectrometria de Massas/métodos , Calibragem , Fluordesoxiglucose F18/normas , Compostos Orgânicos/análiseRESUMO
BACKGROUND/AIMS: Few studies have assessed the prognostic value of the primary tumor maximum standardized uptake value (SUV max) measured by 2-[(18)F]-fluoro-2-deoxy-D-glucose PET-CT for patients with bile duct and gallbladder cancer. METHODS: A retrospective analysis of 61 patients with confirmed bile duct and gallbladder cancer who underwent FDG PET-CT in Kangbuk Samsung Medical Center (Seoul, Korea) from April 2008 to April 2011. Prognostic significance of SUV max and other clinicopathological variables was assessed. RESULTS: Twenty-three patients were diagnosed as common bile duct cancer, 17 as hilar bile duct cancer, 12 as intrahepatic bile duct cancer, and nine as gallbladder cancer. In univariate analysis, diagnosis of intrahepatic cholangiocarcinoma and gallbladder cancer, mass forming type, poorly differentiated cell type, nonsurgical treatment, advanced American Joint Committee on Cancer (AJCC) staging and primary tumor SUV max were significant predictors of poor overall survival. In multivariate analysis adjusted for age and sex, primary tumor SUV max (hazard ratio [HR], 4.526; 95% CI, 1.813-11.299), advanced AJCC staging (HR, 4.843; 95% CI, 1.760-13.328), and nonsurgical treatment (HR, 6.029; 95% CI, 1.989-18.271) were independently associated with poor overall survival. CONCLUSIONS: Primary tumor SUV max measured by FDG PET-CT is an independent and significant prognostic factor for overall survival in bile duct and gallbladder cancer.