Imaging Multiparametric/Multimodality for Lungcancer

NCT ID: NCT02977663

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Lungcancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Magnetic Resonance Imaging (MRI)

Thoracic Magnetic Resonance Imaging (MRI)

Group Type OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type OTHER

* Chest MRI during the MRI cerebral
* 2 tubes of blood taken during the medical visit

Interventions

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Magnetic Resonance Imaging (MRI)

* Chest MRI during the MRI cerebral
* 2 tubes of blood taken during the medical visit

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Electric

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BRILLET

Bobigny, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sabine Helfen

Role: CONTACT

33148957732

Other Identifiers

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ANSM

Identifier Type: REGISTRY

Identifier Source: secondary_id

K160701

Identifier Type: -

Identifier Source: org_study_id

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