NCT03835897

Brief Summary

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:
  • To compare the specificity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer
  • To compare the cancer detection rate of mammography, breast US, contrast-enhanced MRI, and DWI
  • To compare the characteristics of detected cancers

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
890

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

February 7, 2019

Last Update Submit

November 19, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    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 Outcomes (3)

  • Specificity

    Baseline to up to 1 year

  • Cancer detection rate (CDR)

    Baseline to up to 1 year

  • Biologic characteristics of breast cancer

    Baseline to up to 1 year

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

High-risk women for breast cancer

You may qualify if:

  • Women aged between 30 years and 75 years at the time of enrollment
  • 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

You may not qualify if:

  • Women with symptoms or signs of breast cancer or recurrence
  • Women with bilateral mastectomy
  • Pregnant or lactating women
  • Women who undergo chemotherapy due to malignancy in other organs
  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (2)

  • Shin HJ, Lee SH, Park VY, Yoon JH, Kang BJ, Yun B, Kim TH, Ko ES, Han BK, Chu AJ, Park SY, Kim HH, Moon WK. Diffusion-Weighted Magnetic Resonance Imaging for Breast Cancer Screening in High-Risk Women: Design and Imaging Protocol of a Prospective Multicenter Study in Korea. J Breast Cancer. 2021 Apr;24(2):218-228. doi: 10.4048/jbc.2021.24.e19.

    PMID: 33913277DERIVED

  • Ha SM, Chang JM, Lee SH, Kim ES, Kim SY, Kim YS, Cho N, Moon WK. Detection of Contralateral Breast Cancer Using Diffusion-Weighted Magnetic Resonance Imaging in Women with Newly Diagnosed Breast Cancer: Comparison with Combined Mammography and Whole-Breast Ultrasound. Korean J Radiol. 2021 Jun;22(6):867-879. doi: 10.3348/kjr.2020.1183. Epub 2021 Apr 1.

    PMID: 33856137DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Woo Kyung Moon, MD PhD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woo Kyung Moon, MD PhD

CONTACT

+82220722584moonwk@snu.ac.kr

Hee Jung Shin, MD PhD

CONTACT

docshin@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 11, 2019

Study Start

April 3, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations

KR(1)