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

• Status: Suspended
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Angiogenesis Inhibitors; Radiopharmaceuticals

Criteria

Inclusion Criteria:

• 1A. Male or female > 18year old with non-small cell lung carcinoma (NSCLC) meeting the following criteria :

• advanced NSCLC proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled

• Measurable lesions > 1 cm in short axis.

• Pretherapeutic contrast-enhanced CT of thorax and upper abdomen available for masked reading on appropriate medium

• FDG PET/CT available for masked reading on appropriate medium

1B. Male or female > 18year old with head and neck (H&N) cancer meeting the following criteria:

• advanced H&N cancer proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled

• Measurable lesions > 1 cm in short axis.

• Pretherapeutic native and contrast enhanced CT or MRI of the head and neck available for masked reading on appropriate medium

• FDG PET/CT available for masked reading on appropriate medium

• Oto-rhino-laryngologic (ORL) examination including ORL fibroscopy and/or optionally panendoscopy.

2. Capacity to remain without movement during the PET/CT examination 3. ECOG performance status ≤ 2 at inclusion 4. Patient with life expectancy ≥ 24 weeks after inclusion. 5. In fertile females, at inclusion the pregnancy must be ruled out 6. Volunteer and capable to follow necessary instructions during the trial 7. Informed consent signed by the patient 8. Affiliation to a social security system

Exclusion Criteria:

• 1. In patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer.

2. Scheduled treatment which does not include an antiangiogenic agent 3. Patient´s physical condition not permitting participation it clinical trial according to opinion of investigator responsible of the centre 4. Pregnancy or breastfeeding.