NCT02977663

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 8, 2021

Status Verified

December 1, 2020

Enrollment Period

4.9 years

First QC Date

November 10, 2016

Last Update Submit

January 7, 2021

Conditions

Lungcancer

Outcome Measures

Primary Outcomes (1)

  • Event-free survival of patients with lungcancer

    3 years

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Magnetic Resonance Imaging (MRI)

OTHER

Thoracic Magnetic Resonance Imaging (MRI)

Other: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI)OTHER

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

Magnetic Resonance Imaging (MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BRILLET

Bobigny, 93000, France

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Sabine Helfen

CONTACT

33148957732sabine.helfen@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 30, 2016

Study Start

August 28, 2017

Primary Completion

August 1, 2022

Study Completion

August 1, 2023

Last Updated

January 8, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)