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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Advanced Head and Neck Carcinoma focused on measuring Angiogenesis, Integrins, RGD PET/CT, FDG PET/CT, Predictive value, Therapeutic response, Efficacy, Tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Tenon - Assistance Publique-Hôpitaux de Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiopharmaceutical

Arm Description

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)

Outcomes

Primary Outcome Measures

Response to treatment based on RECIST criterion
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

Secondary Outcome Measures

Full Information

First Posted
December 7, 2014
Last Updated
July 18, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02325349
Brief Title
PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents
Acronym
MLAPOCHI
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Change in protocol strategy
Study Start Date
March 20, 2015 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiopharmaceutical
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)
Intervention Description
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 Measure Information:
Title
Response to treatment based on RECIST criterion
Description
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
Time Frame
Pretherapeutic Day-14, Interim Day21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sona BALOGOVA
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Tenon - Assistance Publique-Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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