Clinical trial · Interventional
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
NCT03303846CI-TRIAL-00109060active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.
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 |
|---|---|---|---|
| Healthy Subject | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (breast MRI, biopsy)
- description
- Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery.
- interventionNames
- Procedure: Magnetic Resonance Imaging
- Procedure: Biospecimen Collection
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
- timeFrame
- Up to 12 months
- description
- Development of breast cancers other than triple-negative (e.g. estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) the study analysis, however they will be reported as descriptive statistics.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening * Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery * Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn * Documented informed consent of the participant Exclusion Criteria: * Allergy or intolerance to gadolinium * Inability to undergo breast MRI (e.g. claustrophobia) * Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ) * Previous diagnosis of stage 4 cancer * Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI * Participants who have received endocrine therapy within 1 year prior to screening breast MRI * Participants who have received breast radiation within 1 year prior to screening breast MRI * Radiation to both breasts * Pregnant and/or lactating within 1 year prior to screening breast MRI * Receives screening breast MRIs at an outside facility other than the consenting institution
References
Publications (0)
Data not yet available
No reference posted for this study.