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

Not Applicable

• Conditions: NSCLC
• Interventions: Diagnostic Test: PET-MRI

• Registration Number: NCT03606070
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-25
• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-04
• Primary Completion: 2019-05
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with NSCLC	PET-MRI	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).

Primary Outcome Measures

Name	Time	Method
Measurement of intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping performed before and under treatment.	Up to 24 months

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France