drugset / Trial / NCT02325349

PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents

NCT02325349 ↗

Phase 2 Terminated 1 enrolled Assistance Publique - Hôpitaux de Paris
NaSingle-groupOpen-labelDiagnostic

Summary

The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect. The predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG PET/CT, clinical, endoscopic and histological findings.

Timeline

Start
2015-03-20
Primary completion
2018-09-20
Completion
2018-09-20

Outcome

Outcome not reported

Stopped (Business): “Change in protocol strategy”

Drugs

EvaluationDrugModalityDoseRoute
Subject Flotegatide Diagnostic / imaging agent 2 mbq/kg Intravenous
Subject Flotegatide Diagnostic / imaging agent 4 mbq/kg Intravenous
Subject RGD Diagnostic / imaging agent 2 mbq/kg Intravenous
Subject RGD Diagnostic / imaging agent 4 mbq/kg Intravenous