Trials / Terminated
TerminatedNCT02325349
PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents
PET/CT Molecular Imaging of Angiogenesis in Pulmonary or Head and Neck Cancers Prior to or During Chemotherapy Including Agent With Antiangiogenic Effect. A Prospective Multicentric Study of Efficacy and Tolerability.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Prospective, multicentre, open label, phase II clinical trial with diagnostic radiopharmaceutical on efficacy and tolerability of 18F or 68Ga labelled RGD peptide for detection of malignant tissues expressing integrins, to predict the therapeutic response of lesions of advanced head and neck cancer or advanced non-small cells lung cancer to treatment including an agent with antiangiogenic effect.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | radiopharmaceutical (Flotegatide (18F) or RGD (68Ga) | PET/CT after intravenous administration of 2-4MBq/kg of body weight of Flotegatide (18F) or RGD (68Ga) performed prior and after 2 cycles of chemotherapy including an agent with antiangiogenic effect (two examinations in each patient) |
Timeline
- Start date
- 2015-03-20
- Primary completion
- 2018-09-20
- Completion
- 2018-09-20
- First posted
- 2014-12-25
- Last updated
- 2022-07-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02325349. Inclusion in this directory is not an endorsement.