Imaging Multiparametric/Multimodality for Lungcancer (IRMomics)

Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer

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.

Study Overview

• Status: Recruiting
• Conditions: Lungcancer
• Intervention / Treatment: Other: Magnetic Resonance Imaging (MRI)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabine Helfen; Phone Number: 33148957732; Email: sabine.helfen@aphp.fr

Study Locations

• France
  • Bobigny, France, 93000
    • Recruiting
    • BRILLET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Magnetic Resonance Imaging (MRI); Thoracic Magnetic Resonance Imaging (MRI)	Other: Magnetic Resonance Imaging (MRI); Chest MRI during the MRI cerebral; 2 tubes of blood taken during the medical visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event-free survival of patients with lungcancer	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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
Number of patients with brain metastases	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: General Electric

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: November 10, 2016
• First Submitted That Met QC Criteria: November 25, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: K160701; ANSM (Other Identifier: 2022-A02513-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No