Back to resultsImaging Multiparametric/Multimodality for Lungcancer (IRMomics)
Primary Purpose
Lungcancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI)
Sponsored by
About this trial
This is an interventional other trial for Lungcancer
Eligibility Criteria
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
Sites / Locations
- BRILLETRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Magnetic Resonance Imaging (MRI)
Arm Description
Thoracic Magnetic Resonance Imaging (MRI)
Outcomes
Primary Outcome Measures
Event-free survival of patients with lungcancer
Secondary Outcome Measures
Overall survival
Number of patients by histologic subtypes
Number of patients by mutational profile
Number of patients with metastases
Number of patients with brain metastases
Number of metastases by patient
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))
Full Information
NCT ID
NCT02977663
First Posted
November 10, 2016
Last Updated
January 7, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
General Electric
1. Study Identification
Unique Protocol Identification Number
NCT02977663
Brief Title
Imaging Multiparametric/Multimodality for Lungcancer
Acronym
IRMomics
Official Title
Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
General Electric
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lungcancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Resonance Imaging (MRI)
Arm Type
Other
Arm Description
Thoracic Magnetic Resonance Imaging (MRI)
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
Chest MRI during the MRI cerebral
2 tubes of blood taken during the medical visit
Primary Outcome Measure Information:
Title
Event-free survival of patients with lungcancer
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 months, 1 year, 2 years and 3 years
Title
Number of patients by histologic subtypes
Time Frame
3 months, 1 year, 2 years and 3 years
Title
Number of patients by mutational profile
Time Frame
3 months, 1 year, 2 years and 3 years
Title
Number of patients with metastases
Time Frame
3 months, 1 year, 2 years and 3 years
Title
Number of patients with brain metastases
Time Frame
3 months, 1 year, 2 years and 3 years
Title
Number of metastases by patient
Time Frame
3 months, 1 year, 2 years and 3 years
Title
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))
Time Frame
3 months, 1 year, 2 years and 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Helfen
Phone
33148957732
Email
sabine.helfen@aphp.fr
Facility Information:
Facility Name
BRILLET
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Imaging Multiparametric/Multimodality for Lungcancer
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