Clinical trial · Observational
Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection
NCT02411760CI-TRIAL-00029975BCDcompletedClinicalTrials.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)
In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score, which utilizes both DWI and DCE data. The sensitivity and specificity of each approach will be determined using pathology as the gold standard.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3 Tesla Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic Improvement Gained using an optimized MR Method for Breast Cancer Detection.
- timeFrame
- Each of 60 patients will have 1 60 minute scan prior to biopsy
- description
- The sensitivity and specificity of breast cancer detection using ADC maps acquired with a 31 channel breast coil and improved B0 shimming will be compared to the sensitivity and specificity of cancer detection using DCE MRI.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination. Contraindications to MRI examinations include: Medically unstable * Heart failure * Unstable angina * Child bearing * Lactating Any contraindication per MRI Screening Form (Appendix A attached). * Implants contraindicated at 3T, pacemakers * Poorly controlled diabetes * Body weight greater than 300 pounds * Claustrophobic Since each patient is receiving a gadolinium based contrast agent intravenously: * eGFR \< 60 mL/min/1.73m2 * Sickle cell disease * Hemolytic anemia Subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
References
Publications (0)
Data not yet available
No reference posted for this study.