Clinical trial · Observational
Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer
Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- Baseline to up to 1 year
- description
- 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
Secondary outcomes (3)
- measure
- Specificity
- timeFrame
- Baseline to up to 1 year
- description
- Number of negative examinations without tissue diagnosis of cancer within 1 year / All examinations without tissue diagnosis of cancer within the same period
- measure
- Cancer detection rate (CDR)
- timeFrame
- Baseline to up to 1 year
- description
- Number of detected cancers (invasive and in situ cancer) /1000 examinations
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.).
References
Publications (2)
- DERIVEDShin 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 33913277
- DERIVEDHa 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 33856137