NCT02716051

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

March 14, 2016

Last Update Submit

July 2, 2019

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Th consistency of the locations of mediastinal lesions

    Node localization according to MRI and PET scan measurements on the same day

    Day 1

Study Arms (2)

MRI

EXPERIMENTAL

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

Device: MRI

PET

ACTIVE COMPARATOR

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

Device: PET

Interventions

MRIDEVICE

Whole body MRI with cardiac and pulmonary synchronization

MRI
PETDEVICE
PET

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Limoges

Limoges, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 23, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)