Screening Contrast-enhanced Mammography

June 6, 2023 updated by: CHU de Quebec-Universite Laval

Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion at Screening

The main objective of this study is to compare the diagnostic performance of two diagnostic methods, namely CESM and MRI, in the evaluation of a lesion suspicious of breast cancer in 300 Quebec women referred for the investigation of breast cancer. breast lesion suspected of cancer. All suspicious lesions will be evaluated by these two diagnostic imaging and by TNM. Then, radiologists will respectively interpret diagnostic imaging, without knowing the result of the other imaging in parallel with the study. The sensitivity, specificity, positive predictive value and negative predictive value for his diagnostic imaging will then be determined. Histopathological confirmation by biopsy or surgery will be used as a standard value.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients referred to the breast clinic at the HSS for a mass suspected of cancer (BIRAD 5) will potentially be considered in the study. These women come either from the Quebec breast cancer screening program, or referred by their attending physician in the investigation of a palpable/symptomatic mass or in an investigation requested for a high-risk patient. These patients will then be referred to us by the attending surgeons as part of the preoperative evaluation of the lesion. Preoperatively, mammography (standard or by tomosynthesis) is considered standard and MRI can also be requested as standard by the surgeon. The patients included will be those for whom an MRI will be prescribed. All patients will receive diagnostic imaging (CESM, MRI and TMN) within 30 days of surgery.

Description

Inclusion Criteria:

  • Female aged 18 and over
  • At least one breast lesion with BIRADS classification 5

Exclusion Criteria:

  • Refusal to perform the biopsy or surgery
  • Pregnant or possibly pregnant woman

  • Usual contraindication to contrast product

    • Significant kidney failure
    • Allergy to contrast medium
  • hyperthyroidism
  • Usual contraindications to MRI

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value for breast cancer
Time Frame: Breast cancer screening
To measure sensitivity, specificity, positive predictive value and negative predictive value for CESM and MRI using histopathological confirmation as a standard value.
Breast cancer screening
Diagnostic value for suspicious breast lesion
Time Frame: Breast cancer screening
To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer.
Breast cancer screening

Collaborators and Investigators

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

Sponsor

CHU de Quebec-Universite Laval

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)

December 12, 2018

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-4432

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.

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