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2.
J Nucl Med ; 63(3): 376-383, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34215673

RESUMO

68Ga-satoreotide trizoxetan is a novel somatostatin receptor antagonist associated with high sensitivity and reproducibility in neuroendocrine tumor (NET) detection and localization. However, the optimal peptide mass and radioactivity ranges for 68Ga-satoreotide trizoxetan have not yet been established. We therefore aimed to determine its optimal dosing regimen in patients with metastatic gastroenteropancreatic NETs in a prospective, randomized, 2 × 3 factorial, multicenter phase II study. Methods: Patients received 68Ga-satoreotide trizoxetan at a peptide mass of 5-20 µg on day 1 of the study and of 30-45 µg on days 16-22, at 1 of 3 68Ga radioactivity ranges (40-80, 100-140, or 160-200 MBq). Whole-body PET/CT imaging was performed 50-70 min after each injection. The primary endpoint was the detection rate of NET lesions imaged by 68Ga-satoreotide trizoxetan relative to contrast-enhanced CT (for each of the 6 peptide mass and radioactivity range combinations). Results: Twenty-four patients were evaluated in the per-protocol analysis. The median number of lesions detected by 68Ga-satoreotide trizoxetan PET/CT or PET alone was at least twice as high as the number detected by contrast-enhanced CT across the 6 studied peptide mass and radioactivity range combinations. There were no differences between the 2 peptide mass ranges or between the 3 radioactivity ranges in the number of identified lesions. However, a trend toward a lower relative lesion count was noted in the liver for the 40- to 80-MBq range. No relationship was observed between the radioactivity range per patient's body weight (MBq/kg) and the number of lesions detected by 68Ga-satoreotide trizoxetan. The median diagnostic sensitivity of 68Ga-satoreotide trizoxetan PET/CT, based on the number of lesions per patient, ranged from 85% to 87% across the different peptide mass and radioactivity ranges. Almost all reported adverse events were mild and self-limiting. Conclusion: A radioactivity of 100-200 MBq with a peptide mass of up to 50 µg was confirmed as the optimal dosing regimen for 68Ga-satoreotide trizoxetan to be used in future phase III studies.


Assuntos
Tumores Neuroendócrinos , Compostos Organometálicos , Radioisótopos de Gálio , Humanos , Neoplasias Intestinais , Tumores Neuroendócrinos/patologia , Octreotida , Compostos Organometálicos/efeitos adversos , Neoplasias Pancreáticas , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Estudos Prospectivos , Compostos Radiofarmacêuticos , Reprodutibilidade dos Testes , Neoplasias Gástricas
3.
EJNMMI Res ; 11(1): 84, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34487283

RESUMO

BACKGROUND: 68Ga-satoreotide trizoxetan is a novel somatostatin receptor antagonist exhibiting higher tumour-to-background ratios and sensitivity compared to 68Ga-DOTATOC. This randomised, 2 × 3 factorial, phase II study aimed to confirm the optimal peptide mass and radioactivity ranges for 68Ga-satoreotide trizoxetan, using binary visual reading. To that end, 24 patients with metastatic gastroenteropancreatic neuroendocrine tumours received 5-20 µg of 68Ga-satoreotide trizoxetan on day 1 of the study and 30-45 µg on day 16-22, with one of three gallium-68  radioactivity ranges (40-80, 100-140, or 160-200 MBq) per visit. Two 68Ga-satoreotide trizoxetan PET/CT scans were acquired from each patient post-injection, and were scored by experienced independent blinded readers using a binary system (0 for non-optimal image quality and 1 for optimal image quality). For each patient pair of 68Ga-satoreotide trizoxetan scans, one or both images could score 1. RESULTS: Total image quality score for 68Ga-satoreotide trizoxetan PET scans was lower in the 40-80 MBq radioactivity range (56.3%) compared to 100-140 MBq (90.6%) and 160-200 MBq (81.3%). Both qualitative and semi-quantitative analysis showed that peptide mass (5-20 or 30-45 µg) did not influence 68Ga-satoreotide trizoxetan imaging. There was only one reading where readers diverged on scoring; one reader preferred one image because of higher lesion conspicuity, and the other reader preferred the alternative image because of the ability to identify more lesions. CONCLUSIONS: Binary visual reading, which was associated with a low inter-reader variability, has further supported that the optimal administered radioactivity of 68Ga-satoreotide trizoxetan was 100-200 MBq with a peptide mass up to 50 µg. Trial registration ClinicalTrials.gov, NCT03220217. Registered 18 July 2017, https://clinicaltrials.gov/ct2/show/NCT03220217.

4.
Int J Antimicrob Agents ; 27(3): 242-6, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16464561

RESUMO

A total of 123 clinical isolates of Streptococcus pneumoniae were collected from all over Lebanon and tested for their susceptibility to penicillin: 30.1% were susceptible (minimum inhibitory concentration (MIC) < or = 0.06 microg/mL), 56.1% were intermediately susceptible (MIC 0.09-1.0 microg/mL) and 13.8% were resistant (MIC > 1.0 microg/mL). The oxacillin disk screening test detected all penicillin-resistant isolates, but erroneously designated two penicillin-intermediate isolates as penicillin susceptible. All isolates were consistently susceptible to levofloxacin, but cross-resistance between penicillin and the three tested cephalosporins was frequently noted. The in vitro activity of amoxicillin/clavulanic acid paralleled that of penicillin; however, 92.7% of the isolates were designated as susceptible based on the recommended interpretive cut-off point (MIC < or = 2/1 microg/mL). This discrepancy represents a paradox that deserves serious consideration.


Assuntos
Resistência às Penicilinas , Infecções Pneumocócicas/microbiologia , Streptococcus pneumoniae/efeitos dos fármacos , Líbano , Testes de Sensibilidade Microbiana , Penicilinas/farmacologia , Infecções Pneumocócicas/diagnóstico , Infecções Pneumocócicas/epidemiologia
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