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

Gustave Roussy

Status: Unknown

Conditions: NSCLC

Treatments: Diagnostic Test: PET-MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03606070

2016/2499 (Other Identifier)

2016-A02074-47

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Patients with NSCLC

Other group

Description:

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).

Treatment:

Diagnostic Test: PET-MRI