RESUMO
A quantitative measurement, the Heart-to-Mediastinum (H/M) ratio of counts derived from a planar acquisition approximately 4 hours after injection of 123I-mIBG, is a strong predictor of outcomes in patients with stable class II-III heart failure and LVEF ≤ 35%. This study assessed the test-retest reproducibility of the H/M ratio in such patients. 47 subjects with class II-III systolic heart failure and LVEF ≤ 35% were tested at two time intervals separated by 5 to 14 days. Subjects were imaged twice on the same camera using the same radionuclide dose. Images were sent to a core analysis lab, where three nuclear technologists independently determined the H/M ratios. The primary endpoint was test-retest H/M ratio reproducibility calculated as the absolute difference in mean value determined by the three readers. Mean subject age was 65 ± 12 years, 85% were male, and mean BMI was 29 ± 6 kg/m2. Mean injected activity was 10.18 ± 0.43 mCi for first dose and 10.09 ± 0.52 mCi for the second dose. The mean and SD values for first and repeat studies were almost identical: the 95% confidence interval of the mean test-retest difference was 0.055 to 0.076. Bland-Altman plots showed no systematic effect of the H/M ratio on the magnitude of the difference between replicate measurements. Inter-reader measurements were nearly identical. There were no serious adverse events despite exposure to 123I-mIBG on 2 occasions in a short time period. The Heart-to-Mediastinum ratio of 123I-mIBG is a consistent and highly reproducible measurement in stable Class II to III heart failure patients.
Assuntos
3-Iodobenzilguanidina/farmacologia , Coração/diagnóstico por imagem , Cintilografia , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Cardiomiopatias/diagnóstico por imagem , Feminino , Insuficiência Cardíaca/diagnóstico por imagem , Humanos , Processamento de Imagem Assistida por Computador , Masculino , Mediastino/patologia , Pessoa de Meia-Idade , Compostos Radiofarmacêuticos/farmacologia , Reprodutibilidade dos Testes , Tomografia Computadorizada de Emissão de Fóton Único , Disfunção Ventricular Esquerda/diagnóstico por imagem , Função Ventricular EsquerdaRESUMO
BACKGROUND: Previous clinical studies have shown that iso-osmolar iodixanol (Visipaque®) causes less patient discomfort than low-osmolar contrast media (LOCM) when administered via intra-arterial injection. No data are available comparing these agents for patient discomfort when administered intravenously (i.v.) using power injectors. PURPOSE: To compare the frequency and intensity of patient discomfort between iodixanol and iopamidol (Isovue®) administered i.v. using a power injector in contrast-enhanced computed tomography (CECT) of the abdomen and pelvis. MATERIAL AND METHODS: This was a prospective, randomized, double-blind, multicenter study of iodixanol 320 mg I/mL or iopamidol 370 mg I/mL on patient discomfort. The presence of discomfort (heat, pain, coldness) and intensity was verbally rated by patients on a 0-10 scale and converted into four categories (0, none; 1-3, mild; 4-7, moderate; 8-10, severe). Image quality was evaluated. RESULTS: Of the 299 evaluable patients enrolled at nine centers, 151 received iodixanol and 148 received iopamidol. The average age was 58 years. Iodixanol patients experienced significantly less moderate/severe discomfort (35.1% vs. 67.3%; P < 0.0001) or heat (29.8% vs. 63.9%; P < 0.0001), and severe discomfort (2.6% vs. 16.3%; P = 0.0004) or heat (2.6% vs. 15%; P = 0.0008), but three times more no discomfort (21.2% vs. 7.5%; P = 0.0008) than iopamidol patients. Excellent image quality was in 95.4% of iodixanol vs. 89.9% of iopamidol patients (P = 0.0508). Overall, adverse event (AE) rate excluding patient discomfort was 19.9% in the iodixanol group and 14.9% in the iopamidol group (P = 0.2870), but contrast-related AEs were comparable: 11.3% vs. 10.1% (P = 0.8522). Delayed skin reactions occurred in 2.6% of patients in the iodixanol group and in no patient in the iopamidol group (P = 0.1226). CONCLUSION: Patients receiving iodixanol had significantly lower moderate-to-severe or severe discomfort than patients receiving iopamidol, with heat being the major contributor. Iodixanol use trended towards better image quality but the difference was not statistically significant. No significant differences in incidences of overall or contrast-related AEs or delayed skin reactions were seen between the two groups. These data support that CM osmolality may be a key determinant of patient discomfort.
Assuntos
Meios de Contraste/efeitos adversos , Iopamidol/efeitos adversos , Satisfação do Paciente/estatística & dados numéricos , Pelve/diagnóstico por imagem , Radiografia Abdominal/métodos , Tomografia Computadorizada por Raios X/métodos , Ácidos Tri-Iodobenzoicos/efeitos adversos , Método Duplo-Cego , Disgeusia/induzido quimicamente , Europa (Continente) , Feminino , Cefaleia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Estudos Prospectivos , Radiografia Abdominal/efeitos adversos , Estados UnidosRESUMO
BACKGROUND: An accurate diagnosis is important for timely and adequate treatment in patients with clinically uncertain parkinsonian syndrome (CUPS). OBJECTIVE: The objective of this study was to assess safety and changes in clinical management, diagnosis and quality of life (QoL) at 4 and 12 weeks following DaTscan (ioflupane [(123)I] injection) imaging in patients with CUPS. METHODS: This randomized, open-label, single-dose, multicenter trial was carried out in patients with CUPS who were randomized to either a DaTscan imaging group or to a control group without imaging. The main outcome measures were the proportions of patients with changes in clinical management and diagnosis from baseline through to 12 weeks after DaTscan. A total of 19 university hospital centers in Europe and the USA participated in the study. There were 267 patients enrolled and randomized (131 DaTscan, 136 control). RESULTS: Significantly more DaTscan patients had changes in clinical management after 12 weeks (p = 0.004) compared to the control group, and significantly more DaTscan patients had changes in diagnosis at 4 weeks and at 12 weeks (both p < 0.001) compared to control patients. No significant difference in total score for QoL was observed between groups during the study duration. DaTscan was safe and well-tolerated. No deaths, serious adverse events (AEs) or withdrawals due to AEs occurred during the study. One patient had a headache following treatment with a suspected relationship to DaTscan. CONCLUSION: DaTscan imaging significantly affected the clinical management and diagnosis of patients with CUPS. DaTscan is safe and well-tolerated and is a useful adjunct to differential diagnosis of CUPS.
Assuntos
Antiparkinsonianos/uso terapêutico , Transtornos Parkinsonianos/diagnóstico por imagem , Transtornos Parkinsonianos/diagnóstico , Transtornos Parkinsonianos/tratamento farmacológico , Tomografia Computadorizada de Emissão de Fóton Único/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Iofetamina , Masculino , Pessoa de Meia-Idade , Transtornos Parkinsonianos/psicologia , Qualidade de Vida , Compostos Radiofarmacêuticos , Índice de Gravidade de Doença , Método Simples-Cego , Fatores de Tempo , Adulto JovemRESUMO
BACKGROUND: This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS). METHODS: A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups. RESULTS: There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration. CONCLUSIONS: DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967.
Assuntos
Gerenciamento Clínico , Radioisótopos do Iodo , Nortropanos , Transtornos Parkinsonianos/diagnóstico , Transtornos Parkinsonianos/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Qualidade de Vida/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos Parkinsonianos/diagnóstico por imagem , Valor Preditivo dos Testes , Estudos Prospectivos , Segurança/estatística & dados numéricos , Tomografia Computadorizada de Emissão de Fóton Único/métodos , Tomografia Computadorizada de Emissão de Fóton Único/psicologiaRESUMO
PURPOSE: To compare a technetium 99m-labeled murine immunoglobulin M monoclonal antigranulocyte antibody that binds to human polymorphonuclear leukocyte CD15 antigens with indium 111 ((111)In)-labeled leukocytes in the diagnosis of appendicular skeletal osteomyelitis. MATERIALS AND METHODS: Twenty-four patients suspected of having infected joint replacement (n = 12), diabetic pedal osteomyelitis (n = 8), or long bone osteomyelitis (n = 4) were imaged 5, 30, 60, and 120 minutes after antibody injection. Following injection, one patient experienced moderate joint pain exacerbation that resolved spontaneously. Patients underwent imaging with (111)In-labeled leukocytes and three-phase bone imaging. All studies were interpreted alone. Images obtained in antibody and (111)In-labeled leukocyte studies were also interpreted with the bone scans. One reader, without knowledge of other study results or final diagnoses, reviewed and interpreted images in a random order. Sensitivity, specificity, and accuracy were calculated for the antibody study at each time point, the (111)In-labeled leukocyte study, the three-phase bone scanning procedure, and dual-tracer studies. RESULTS: There were 11 cases of osteomyelitis. Bone scintigraphy was sensitive (1.0) but nonspecific (0.38). Images obtained in the 120-minute antibody study were sensitive (0.91), moderately specific (0.69), and comparable to those obtained in the (111)In-labeled leukocyte study (0.91 sensitivity, 0.62 specificity). When interpreted with bone scans, images obtained in the antibody and (111)In-labeled leukocyte studies showed improved sensitivity and specificity (1.0 and 0.85 and 1.0 and 0.77, respectively). CONCLUSION: Use of the monoclonal antigranulocyte antibody was comparable to the use of (111)In-labeled leukocytes in the diagnosis of appendicular skeletal osteomyelitis. The combined results of the monoclonal antibody study and bone scanning were more accurate (0.91) for diagnosing this entity than were the results of any of the other studies.
Assuntos
Anticorpos Monoclonais , Radioisótopos de Índio , Osteomielite/diagnóstico por imagem , Compostos Radiofarmacêuticos , Medronato de Tecnécio Tc 99m , Idoso , Idoso de 80 Anos ou mais , Feminino , Granulócitos/imunologia , Humanos , Leucócitos , Masculino , Pessoa de Meia-Idade , Cintilografia , Sensibilidade e EspecificidadeRESUMO
An in vivo method of labeling white cells that diagnoses diabetic pedal osteomyelitis safely, rapidly, and accurately is desirable. The objectives of this investigation were to evaluate a technetium-99m-labeled monoclonal antigranulocyte antibody for diagnosing diabetic pedal osteomyelitis, compared with indium-111-labeled leukocyte and 3-phase bone imaging for this purpose. Twenty-five diabetic patients with pedal ulcers, 22 in the forefoot and 3 in the midfoot, underwent antibody, indium-111-labeled leukocyte, and technetium-99m methylene diphosphonate 3-phase bone imaging. The 1-hour antibody, 24-hour labeled leukocyte, and 3-phase bone images were interpreted separately for the presence of osteomyelitis. The antibody and labeled leukocyte images also were interpreted together with the bone images to determine if the combined study was more accurate than each individual study. There were 10 cases of osteomyelitis among the 25 patients. The sensitivity, specificity, and accuracy of the antibody were.90,.67, and.76, respectively. These results were not significantly different from those obtained with labeled leukocyte imaging:.80,.67, and.72, respectively. The antibody was significantly more specific (P =.004) than 3-phase bone imaging (.27). Interpreting the antibody together with the bone scan did not alter the results. When interpreted with the bone images, the accuracy of labeled leukocyte imaging improved from.72 to.80. This was not significantly more accurate than either the antibody or labeled leukocyte imaging alone. The data suggest that the monoclonal antigranulocyte antibody is comparable with in vitro labeled leukocyte imaging for diagnosing pedal osteomyelitis in diabetic patients, and warrants further investigation in a larger population.
Assuntos
Anticorpos Monoclonais , Pé Diabético/complicações , Osteomielite/diagnóstico por imagem , Tecnécio , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Granulócitos/diagnóstico por imagem , Granulócitos/imunologia , Humanos , Radioisótopos de Índio , Leucócitos/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Osteomielite/complicações , Cintilografia , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Appendicitis frequently presents in an atypical fashion leading to misdiagnosis or a delay in diagnosis. This is particularly true in early cases where the patient may be erroneously discharged from an emergency department and will invariably return with perforated appendicitis. The standard of care is hospital admission for observation or early operation. Adjunctive imaging tests have been used with mixed results in this equivocal patient population. The authors studied a promising new monoclonal antibody, 99mTc-labeled anti-CD 15 (LeuTech; Palatin Technologies, Inc., Princeton, NJ), which specifically targets neutrophils and may be used for imaging appendicitis. This prospective, multicenter, open-label study evaluated the diagnostic efficacy and clinical impact of LeuTech scintigraphy for detecting appendicitis in patients with an equivocal presentation. METHODS: A total of 200 patients (121 females, 79 males; age range 5-86 years; mean age 30.5 +/- 16.5 years) completed the study. Management plan was formulated before and reassessed following LeuTech imaging to determine impact on management. Following intravenous injection of LeuTech, the abdomen was imaged with a standard gamma camera for 30 to 90 minutes. RESULTS: Fifty-nine patients had a histopathologic diagnosis of acute appendicitis. LeuTech identified 53 of 59 patients with appendicitis (90% sensitivity) and was negative in 122 of 141 patients without appendicitis (87% specificity). Accuracy, positive predictive value, and negative predictive value were 88%, 74%, and 95%, respectively. Diagnostic efficacy was unchanged in a subgroup of 48 pediatric patients (5-17 years). Diagnostic images for appendicitis were achieved within 8 minutes postinjection in 50% of patients and within 47 minutes in 90% of patients. Significant shifts in patient management decisions were evident following LeuTech results. LeuTech was well tolerated with no serious adverse events reported. CONCLUSION: LeuTech is a convenient, safe, rapid, and sensitive imaging test for diagnosis of appendicitis and favorably impacts patient management in adult and pediatric patients with equivocal signs and symptoms.