Clinical trial · Observational
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing
Surveillance for Second Breast Cancer With Abbreviated Breast MRI, Ultrasound, and Mammography in Women With BRCA Mutation Testing
- 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)
Study Purpose: A multicenter prospective study to evaluate the outcome of second breast cancer surveillance with abbreviated breast MR (AB-MR) or ultrasound (US) in addition to annual mammography in women with BRCA1/2 mutation testing Study Scheme: * AB-MR, US, and digital mammography will be performed on the same day and interpreted independently at baseline and then after 1 year. * After completion of study, patients are followed-up for at least 1 year.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metachronous Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and Specificity (co-primary)
- timeFrame
- 1 year
- description
- To compare the sensitivity and specificity of AB-MR, US, and mammography for the detection of secondary breast cancer
Secondary outcomes (4)
- measure
- Cancer detection rate (CDR)
- timeFrame
- 1 year
- description
- To compare the CDR (no. of detected cancers/1,000 examinations) of AB-MR, US, and mammography
- measure
- Positive predictive value (PPV)
- timeFrame
- 1 year
- description
- To compare the PPV (no. of detected cancers / no. of positive examinations) of AB-MR, US, and mammography
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged between 25 years and 75 years with a personal history of breast cancer * BRCA mutation test done (meeting any of the following criteria): 1) early-age-onset breast cancer (40 years or younger), 2) bilateral breast cancers (synchronous) 3) personal history of ovarian cancer and/or other multiple primary cancers 4) family history of breast and/or ovarian cancer in first- or second-degree relatives * No symptom or sign of secondary breast cancer (no palpable mass, bloody nipple discharge, abnormal skin change, nipple retraction) * Written informed consent is given Exclusion criteria: * Initial breast cancer stage IV * Bilateral mastectomy done * Diagnosis of second breast cancer or regional/distant metastasis * Systemic chemotherapy for any cancer * Pregnant or lactating * Contraindication to breast MRI with contrast enhancement
References
Publications (0)
Data not yet available