Imaging Multiparametric/Multimodality for Lungcancer

Lungcancer Clinical Trial

— IRMomics  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977663
• Other study ID #: K160701
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: August 28, 2017
• Est. completion date: August 2023

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sabine Helfen
• Phone: 33148957732
• Email: sabine.helfen[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Lungcancer

Intervention

Other:
• Magnetic Resonance Imaging (MRI)
Chest MRI during the MRI cerebral 2 tubes of blood taken during the medical visit

Locations

Country	Name	City	State
France	BRILLET	Bobigny

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	General Electric

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival of patients with lungcancer		3 years
Secondary	Overall survival		3 months, 1 year, 2 years and 3 years
Secondary	Number of patients by histologic subtypes		3 months, 1 year, 2 years and 3 years
Secondary	Number of patients by mutational profile		3 months, 1 year, 2 years and 3 years
Secondary	Number of patients with metastases		3 months, 1 year, 2 years and 3 years
Secondary	Number of patients with brain metastases		3 months, 1 year, 2 years and 3 years
Secondary	Number of metastases by patient		3 months, 1 year, 2 years and 3 years
Secondary	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