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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03835897
• Other study ID #: Breast Screening with DWI
• Status: Recruiting
• 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
• 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.).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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