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Wholebody MRI In Lung Cancer StagiNg (WISLON)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
PET
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years,
  • Neoplasia bronchopulmonary (SCLC and NSCLC) newly diagnosed,
  • Patient potentially eligible for curative treatment, but no no treatment started,
  • Patients for whom a PET scan and MRI are planned

Non Inclusion Criteria:

  • claustrophobia,
  • Implantable Medical Device
  • not compatible pacemaker type or heart valve, metal splinters eye)
  • Pregnant or lactating women,

Sites / Locations

  • CHU Limoges

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MRI

PET

Arm Description

Wholebody MRI with cardio-pulmonary synchronization At day 1 , at the afternoon, patient will undergo an MRI analysis.

At day 1 , in the morning, patient will undergo an PET analysis

Outcomes

Primary Outcome Measures

Th consistency of the locations of mediastinal lesions
Node localization according to MRI and PET scan measurements on the same day

Secondary Outcome Measures

Full Information

First Posted
March 14, 2016
Last Updated
July 2, 2019
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT02716051
Brief Title
Wholebody MRI In Lung Cancer StagiNg
Acronym
WISLON
Official Title
Initial Staging of Bronchopulmonary Neoplasia: Whole-body MRI Versus Pet Scanner
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in detection of nodes in patients with cell lung cancer (NSCLC). However, the cardiorespiratory synchronization in the MRI, allowing acquisition of synchronous images with breathing and heart movements should increase the sensitivity of detection of pathologic mediastinal lymph nodes. Given its high sensitivity, whole-body MRI with diffusion could possibly be at least as informative as PET, while being less expensive, not radiant. The purpose of this study is to evaluate the performance of whole-body MRI with diffusion with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are known to be less well detected by MRI) compared to PET.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI
Arm Type
Experimental
Arm Description
Wholebody MRI with cardio-pulmonary synchronization At day 1 , at the afternoon, patient will undergo an MRI analysis.
Arm Title
PET
Arm Type
Active Comparator
Arm Description
At day 1 , in the morning, patient will undergo an PET analysis
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
Whole body MRI with cardiac and pulmonary synchronization
Intervention Type
Device
Intervention Name(s)
PET
Primary Outcome Measure Information:
Title
Th consistency of the locations of mediastinal lesions
Description
Node localization according to MRI and PET scan measurements on the same day
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years, Neoplasia bronchopulmonary (SCLC and NSCLC) newly diagnosed, Patient potentially eligible for curative treatment, but no no treatment started, Patients for whom a PET scan and MRI are planned Non Inclusion Criteria: claustrophobia, Implantable Medical Device not compatible pacemaker type or heart valve, metal splinters eye) Pregnant or lactating women,
Facility Information:
Facility Name
CHU Limoges
City
Limoges
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Wholebody MRI In Lung Cancer StagiNg

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