drugset / Trial / NCT02325349
PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |