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

NCT03606070 | Terminated

• 2 other identifiers: 2016-A02074-472016/2499
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Measurement of intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping performed before and under treatment.

  Up to 24 months

Study Arms (1)

Patients with NSCLC

OTHER

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).

Diagnostic Test: PET-MRI

Interventions

PET-MRI 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).

Patients with NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced NSCLC (stages IIB, IIIA or IIIB of the TNM classification 7th edition) or trace metastatic stage IV (\</=5 mestastasis, \</= 3 organ reached)
• Exclusive therapeutic management by concomitant radio-chemotherapy administered in accordance with international recommendations (dual therapy with platinum salts)
• Signed consent
• Patients affiliated with the social security scheme or beneficiary of a similar scheme.

You may not qualify if:

• Minor
• Pregnant / lactating woman
• 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
• Previous cancer in the 2 years prior to registration
• Previousradiotherapy / thoracic surgery
• Patients under experimental treatment or for whom the administration of an experimental treatment is planned
• Claustrophobic patients
• Severe Renal Insufficiency (Clearance MDRD Cockroft \<30ml / min)
• Uncontrolled diabetes, hyperglycemia\> 1.8g / L
• Patient with metallic implants not compatible with MRI or any immovable implanted electronic medical device (eg pacemaker, neurostimulator, cochlear implants, etc.)

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 30, 2018
• Study Start: November 25, 2017
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)