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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT03606070

Collaborator

(none)

Enrollment

Location

Arm

35.2

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Diagnostic Test: PET-MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Nov 25, 2017

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	Diagnostic Test: 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).

Arm

Intervention/Treatment

Other: 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).

Diagnostic Test: 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).

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy	Villejuif	Val De Marne	France	94805

Sponsors and Collaborators

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gustave Roussy, Cancer Campus, Grand Paris

ClinicalTrials.gov Identifier:

NCT03606070

Other Study ID Numbers:

2016-A02074-47
2016/2499

First Posted:

Jul 30, 2018

Last Update Posted:

Jan 4, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jan 4, 2019