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

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ClinicalTrials.gov Identifier: NCT03835897
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Woo Kyung Moon, Seoul National University Hospital

Tracking Information
First Submitted Date February 7, 2019
First Posted Date February 11, 2019
Last Update Posted Date March 4, 2019
Estimated Study Start Date March 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 7, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03835897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 7, 2019)
  • 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
  • Cancer detection rate (CDR) [ Time Frame: Baseline to up to 1 year ]
    Number of detected cancers (invasive and in situ cancer) /1000 examinations
  • Biologic characteristics of breast cancer [ Time Frame: Baseline to up to 1 year ]
    histologic type, tumor grade, and molecular subtype of breast cancers
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer
Official Title Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer
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:

    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
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 and 1000 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population High-risk women for breast cancer
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: February 7, 2019)
890
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2022
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.).
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Woo Kyung Moon, MD PhD +82220722584 moonwk@snu.ac.kr
Contact: Hee Jung Shin, MD PhD docshin@amc.seoul.kr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03835897
Other Study ID Numbers Breast Screening with DWI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Woo Kyung Moon, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Woo Kyung Moon, MD PhD Professor
PRS Account Seoul National University Hospital
Verification Date February 2019