Use of Compressed Sensing in Breast MRI (COMPRIM)

August 7, 2018 updated by: Institut de Cancérologie de Lorraine

Breast MRI is increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.

These curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.

It seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre-Lès -Nancy, France, 54500
        • Institut de Cancerologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient to benefit a MRI in the assessment for a breast carcinoma
  • Age >18 years old
  • Assessment on 3.0 Tesla in Magnetic Resonance Imaging
  • ECOG performance status ≤ 3
  • Ability to provide an informed written consent form

Exclusion Criteria:

  • Age < 18 years old
  • Claustrophobia
  • Contraindication to the injection of gadolinium contrast medium
  • Contraindication to MRI
  • Persons deprived of liberty or under supervision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3.0 Tesla in Magnetic Resonance Imaging
Other: 3.0 Tesla in Magnetic Resonance Imaging

Eligible patient will have a standard MRI. The images taken before 4min30 and after 6min after to the injection of gadolimium contrast medium will be carried out with the standard image acquisition.

The images taken between 4min30 and 6min after the injection of gadolimium contrast medium will be carried out with the compressed sensing image acquisition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between compressed sensing and standard image acquisition
Time Frame: 1 day
Agreement between compressed sensing and standard image acquisition is defined by percentage of lesions detected by both modes of acquisitions
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of dammage contours
Time Frame: 1 day
Analysis of lesions contours will be performed according to Bi-RADS classification
1 day
Image quality in compressed sensing acquisition
Time Frame: 1 day
The image quality will be evaluated using a quality scale
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: OLDRINI Guillaume, MD, Institut de Cancerologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2016

Primary Completion (Actual)

April 12, 2016

Study Completion (Actual)

April 12, 2016

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-A00581-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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