drugset / Trial / NCT01801371

68Ga-BNOTA-PRGD2 PET/CT in Diagnosis and Evaluation of Glioma

NCT01801371 ↗

NaSingle-groupOpen-labelDiagnostic

Summary

This is an open-label brain PET/CT (positron emission tomography/computed tomography) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in glioma patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤40 µg BNOTA-PRGD2) will be intravenously injected into patients in suspicion of glioma. Visual and semiquantitative method will be used to assess the PET/CT images. Brain MRI with/without enhancement and 18F-FDG PET/CT will be performed for comparison. The postoperative pathology and integrin αvβ3 and CD34 immunohistochemical stains will also be used for correlation.

Timeline

Start
2012-10
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-BNOTA-PRGD2 Diagnostic / imaging agent 40 ug Intravenous
Subject 68Ga-BNOTA-PRGD2 Diagnostic / imaging agent 111 mbq Intravenous

Indications