Imaging Multiparametric/Multimodality for Lungcancer

Not Applicable

• Conditions: Lungcancer
• Interventions: Other: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT02977663
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank...), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).

2. To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.

3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-30
• Study Start: 2017-08-28
• Status Verified: 2020-12
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08
• Primary Completion: 2022-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults over 18 years
• High suspicion of lungcancer confirmed
• Tumor > 2 cm
• Incomplete cerebral staging or not yet realized in the initial consultation of screening

Exclusion Criteria

• Lungcancer medical history
• During Pregnancy
• Contraindications to MRI
• Patient not able to understand the information of the protocol, taking into account the state of the brain
• Patient unable to keep lying in MRI the necessary time

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic Resonance Imaging (MRI)	Magnetic Resonance Imaging (MRI)	Thoracic Magnetic Resonance Imaging (MRI)

Primary Outcome Measures

Name	Time	Method
Event-free survival of patients with lungcancer	3 years

Secondary Outcome Measures

Name	Time	Method
Number of patients by mutational profile	3 months, 1 year, 2 years and 3 years
Number of patients with metastases	3 months, 1 year, 2 years and 3 years
Overall survival	3 months, 1 year, 2 years and 3 years
Number of patients by histologic subtypes	3 months, 1 year, 2 years and 3 years
Number of metastases by patient	3 months, 1 year, 2 years and 3 years
Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))	3 months, 1 year, 2 years and 3 years
Number of patients with brain metastases	3 months, 1 year, 2 years and 3 years

Trial Locations

Locations (1)

BRILLET; 🇫🇷 Bobigny, France