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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03835897
Other study ID # Breast Screening with DWI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2019
Est. completion date December 2022

Study information

Verified date November 2020
Source Seoul National University Hospital
Contact Woo Kyung Moon, MD PhD
Phone +82220722584
Email moonwk@snu.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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: 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 890
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Specificity 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
Secondary Cancer detection rate (CDR) Number of detected cancers (invasive and in situ cancer) /1000 examinations Baseline to up to 1 year
Secondary Biologic characteristics of breast cancer histologic type, tumor grade, and molecular subtype of breast cancers Baseline to up to 1 year
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