Multiparametric PET-MRI Integration for a New Approach to Tumor Heterogeneity in Non-Small Cell Lung Cancer (NSCLC): Pilot Study

NCT ID: NCT03606070

Last Updated: 2019-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-25
• Study Completion Date: 2020-11-30

Brief Summary

To estimate the intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping in locally advanced and trace mestastatic non-small cell lung cancer (NSCLC).

Conditions

NSCLC

Study Design

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

Study Groups

Patients with NSCLC

Characterization of tumor heterogeneity by multiparametric regional mapping PET-MRI.

Patients will realize:

• a PET-MRI examination performed before the chemoradiotherapy treatment (so-called baseline PET-MRI)
• a PET-MRI examination performed midway through treatment (PET-MRI1 under treatment), after receiving 33 ± 4 Gy (approximately 2.5 months after the first PET-MRI).

Group Type: OTHER

PET-MRI

Intervention Type: DIAGNOSTIC_TEST

• a PET-MRI examination performed before the chemoradiotherapy treatment (so-called baseline PET-MRI)
• a PET-MRI examination performed midway through treatment (PET-MRI1 under treatment), after receiving 33 ± 4 Gy (approximately 2.5 months after the first PET-MRI).

Interventions

PET-MRI

• a PET-MRI examination performed before the chemoradiotherapy treatment (so-called baseline PET-MRI)
• a PET-MRI examination performed midway through treatment (PET-MRI1 under treatment), after receiving 33 ± 4 Gy (approximately 2.5 months after the first PET-MRI).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Locally advanced NSCLC (stages IIB, IIIA or IIIB of the TNM classification 7th edition) or trace metastatic stage IV (</=5 mestastasis, </= 3 organ reached)

2. Exclusive therapeutic management by concomitant radio-chemotherapy administered in accordance with international recommendations (dual therapy with platinum salts)

3. Signed consent

4. Patients affiliated with the social security scheme or beneficiary of a similar scheme.

Exclusion Criteria

1. Minor

2. Pregnant / lactating woman

3. Person deprived of liberty by judicial or administrative decision, adults who are the subject of a legal protection measure or unable to express their consent

4. Previous cancer in the 2 years prior to registration

5. Previousradiotherapy / thoracic surgery

6. Patients under experimental treatment or for whom the administration of an experimental treatment is planned

7. Claustrophobic patients

8. Severe Renal Insufficiency (Clearance MDRD Cockroft <30ml / min)

9. Uncontrolled diabetes, hyperglycemia> 1.8g / L

10. Patient with metallic implants not compatible with MRI or any immovable implanted electronic medical device (eg pacemaker, neurostimulator, cochlear implants, etc.)

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

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, Val De Marne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Caroline CARAMELLA, MD

Role: CONTACT

caroline.caramella@gustaveroussy.fr

0142114211 ext. +33

Facility Contacts

Caroline CARAMELLA, MD

Role: primary

caroline.caramella@gustaveroussy.fr

0142114211

Other Identifiers

2016/2499

Identifier Type: OTHER

Identifier Source: secondary_id

2016-A02074-47

Identifier Type: -

Identifier Source: org_study_id