Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer

November 19, 2020 updated by: Woo Kyung Moon, Seoul National University Hospital

Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer

A prospective observational multicenter study to compare the outcome of breast cancer surveillance using mammography, breast US, contrast-enhanced MRI, and diffusion-weighted MR imaging (DWI) as a screening tool, in the high-risk women for breast cancer.

  • Primary objective: To compare the sensitivity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer

  • Secondary objective:

    1. To compare the specificity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer
    2. To compare the cancer detection rate of mammography, breast US, contrast-enhanced MRI, and DWI
    3. To compare the characteristics of detected cancers

Study Overview

Status

Unknown

Conditions

Detailed Description

  • Mammography, breast US, contrast-enhanced MRI, and DWI will be performed on the same day or within 1 month at baseline and then after 1 year, and images will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
  • Each eligible woman, who provides informed consent for this study, will undergo mammography, breast US, contrast-enhanced MRI, and DWI at a 3T MR scanner.
  • Contrast-enhanced breast MRI will be performed before and after a gadolinium-based contrast agent injection.
  • Before contrast injection, DWI with b-value of 0, 800 and 1200 s/mm2 will be performed and will transfer into the server.
  • A total of 890 high-risk women for breast cancer will be enrolled in this study.
  • The BI-RADS 3 or higher is defined as test-positive. The reference standard will be a biopsy or at least 1 year of follow-up.

Study Type

Observational

Enrollment (Anticipated)

890

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

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

High-risk women for breast cancer

Description

Inclusion Criteria:

  1. Women aged between 30 years and 75 years at the time of enrollment
  2. Breast cancer high-risk women who meet one or more of the following criteria: 1) BRCA mutation carrier or untested first-degree relative of BRCA mutation carrier 2) Family history of breast cancer in first- or second-degree relatives and lifetime risk >20% calculated by the Tyrer-Cuzick model 3) Family history of breast cancer in first- or second-degree relatives and personal history of breast cancer 4) Lobular carcinoma in situ, atypical ductal hyperplasia, or atypical lobular hyperplasia on previous biopsy or surgery and lifetime risk >20% calculated by the Tyrer-Cuzick model 5) Thoracic radiation therapy between the ages of 10 and 30

Exclusion Criteria:

  1. Women with symptoms or signs of breast cancer or recurrence
  2. Women with bilateral mastectomy
  3. Pregnant or lactating women
  4. Women who undergo chemotherapy due to malignancy in other organs
  5. In cases of contraindications to MRI using contrast media (claustrophobia, renal insufficiency GFR<30mL/min/1.73m2, metallic foreign body such as pacemaker or clips, history of severe side effects due to MR contrast agent, etc.).

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
Sensitivity
Time Frame: Baseline to up to 1 year
Number of positive examinations with a tissue diagnosis of cancer within 1 year / All cancers present in the population examined in the same time period
Baseline to up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Baseline to up to 1 year
Number of negative examinations without tissue diagnosis of cancer within 1 year / All examinations without tissue diagnosis of cancer within the same period
Baseline to up to 1 year
Cancer detection rate (CDR)
Time Frame: Baseline to up to 1 year
Number of detected cancers (invasive and in situ cancer) /1000 examinations
Baseline to up to 1 year
Biologic characteristics of breast cancer
Time Frame: Baseline to up to 1 year
histologic type, tumor grade, and molecular subtype of breast cancers
Baseline to up to 1 year

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Woo Kyung Moon, MD PhD, PROFESSOR

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)

April 3, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (Actual)

February 11, 2019

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast Screening with DWI

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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