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

Phase 2

Terminated

• Conditions: Advanced Head and Neck Carcinoma; Advanced Non-small Cell Lung Carcinoma
• Interventions: Drug: radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)

• Registration Number: NCT02325349
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Study Timeline

• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-24
• Study First Posted: 2014-12-25
• Study Start: 2015-03-20
• Primary Completion: 2018-09-20
• Study Completion: 2018-09-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiopharmaceutical	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)

Primary Outcome Measures

Name	Time	Method
Response to treatment based on RECIST criterion	Pretherapeutic Day-14, Interim Day21	The value of pretherapeutic and interim RGD PET/CT (Pretherapeutic: D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) to early predict the therapeutic response of head and neck cancer or non-small cell lung cancer to chemotherapy with antiangiogenic agent. Final therapeutic response will be assessed at the end of the treatment, up to 24 weeks after first examination, according to criteria RECIST 1.1.; Potential risk for the patient: two intravenous administrations of investigational product (Pretherapeutic : D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) each of them followed by PET/CT acquisition

Trial Locations

Locations (1)

Hôpital Tenon - Assistance Publique-Hôpitaux de Paris; 🇫🇷 Paris, France