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

NCT ID: NCT02325349

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-20
• Study Completion Date: 2018-09-20

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.

Conditions

Advanced Head and Neck Carcinoma; Advanced Non-small Cell Lung Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

radiopharmaceutical

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)

Group Type: EXPERIMENTAL

radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sona BALOGOVA

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Tenon - Assistance Publique-Hôpitaux de Paris

Paris, , France

Countries

France

Other Identifiers

2014-000553-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P110154

Identifier Type: -

Identifier Source: org_study_id