Clinical trial NCT02325349: PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Head and Neck Carcinoma
Advanced Non-small Cell Lung Carcinoma
Keywords: Angiogenesis
Integrins
RGD PET/CT
FDG PET/CT
Predictive value
Therapeutic response
Efficacy
Tolerability
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Response to treatment based on RECIST criterion
timeFrame: Pretherapeutic Day-14, Interim Day21
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Tenon - Assistance Publique-Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sona BALOGOVA
role: PRINCIPAL_INVESTIGATOR
References: