Status:
UNKNOWN
Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer
Lead Sponsor:
Seoul National University Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-75 years
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 scr...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.).
Key Trial Info
Start Date :
April 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
890 Patients enrolled
Trial Details
Trial ID
NCT03835897
Start Date
April 3 2019
End Date
December 1 2022
Last Update
November 23 2020
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea