Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.

April 16, 2019 updated by: Dr Divano Luisa, Brugmann University Hospital

Mammography remains an imperfect screening test especially in women with extremely dense breast tissue, missing biologically aggressive cancers especially in younger population and picking up indolent cancers that do not need treatment.

The most sensitive test for breast cancer detection at our disposal is magnetic resonance imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and specificity values.

Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer screening: it is safe, does not induce cancers, and can find more cancers than mammography.

However this study was performed in women with low to moderately increased risk.The value of FAST Breast Magnetic Resonance in normal screening population has to be assessed before a modification of current strategy of breast cancer screening with mammography.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women referred for routine breast cancer screening

Exclusion Criteria:

  • Disabled women (eg, unable to stand)
  • Pregnant women
  • Allergy to Gadolinium

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MRI screening
Diagnostic screening. The normal eligible screening population will first undergo a mammography, then an echography screening followed by a fast MRI screening.
Procedure: MRI screening
Diagnostic screening. The normal eligible screening population will first undergo a mammography, then an echography screening followed by a fast MRI screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR five point rating scale for mammography images
Time Frame: 24h
Two views (craniocaudal and mediolateral oblique) will be obtained of each breast with digital mammography by using a commercially available system. The reader will first interpret the digital mammography using a dedicated workstation.The radiologist will rate the images from each examination by using a standardized ACR five-point rating scale. Furthermore, if a reader records a positive score (>2), mammographic features have to be specified (localization, number of ACR>2 lesions,using predefined evaluation form). Scores are recorded directly into the PACS database and locked after each reading session.
24h
ACR five point rating scale for echography images
Time Frame: 24h
After the digital mammography, the same reader will perform Ultrasound of both breasts using the transmitter of 10-13 MHertz (Acuson Antares (Siemens)). The reader will then interpret the ultrasound images using the same methodology as for digital mammography, described above (ACR five point rating scale).
24h
ACR five point rating scale for MRI imaging
Time Frame: 24h
The same day, the Ultra FAST Breast Magnetic Resonance will be performed on 3T unit with 8 channel dedicated breast coil. Sequences: 3 Dimensional Gradient echo with Fat Saturation before and after Gadolinium injection (acquisition time 2 minutes). Initial post processing: MPR and automatic subtraction. The reader has to assess the MRI images using the same methodology as for digital mammography, according to the American College of Radiology Breast Imaging Reporting and Data System.
24h

Collaborators and Investigators

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

Sponsor

Brugmann University Hospital

Investigators

  • Principal Investigator: Tadeusz Stadnik, MD, PhD, CHU Brugmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2015

Primary Completion (Actual)

April 16, 2019

Study Completion (Actual)

April 16, 2019

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-FastMRI-BCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Breast Cancer

Clinical Trials on MRI screening

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe