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NCT03606070 Clinical Trial

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

NSCLC Clinical Trial

— IMAHTEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03606070
Other study ID # 2016-A02074-47
Secondary ID 2016/2499
Status Recruiting
Phase N/A
First received
Last updated
Start date November 25, 2017
Est. completion date November 2020

Study information
Verified date January 2019
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact Caroline CARAMELLA, MD
Phone 0142114211
Email caroline.caramella@gustaveroussy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 2020
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
France Gustave Roussy Villejuif Val De Marne

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of intra and inter-operator reproducibility of multiparametric regional PET-MRI mapping performed before and under treatment. Up to 24 months
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