Clinical trial · Interventional
Importance of Magnetic Resonance Imaging (MRI) in Treating Breast Cancer
Breast Cancer Staging MAgnetic Resonance for Treatment (B-SMART)
NCT00948285CI-TRIAL-00041594BSMARTterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficult accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine if the use of magnetic resonance imaging (MRI) for breast cancer translates into better surgical outcomes. MRIs may help ensure that as little healthy tissue is removed as is possible and may help prevent the need for additional surgical procedures.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRI
- description
- Preoperative staging with mammogram, ultrasound, and MRI, followed by surgery (n=200)
- interventionNames
- Procedure: MRI
- type
- NO_INTERVENTION
- label
- Non-MRI
- description
- Preoperative staging with mammogram and ultrasound alone, followed by surgery (n=200)
Primary outcomes (1)
- measure
- A difference of 10% in the margin revision rate in women undergoing breast conservation for cancer.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed breast cancer patients * Breast cancer patients identified as conservation candidates by their surgeons Exclusion Criteria: * Patients with a history of prior breast cancer treatment (recurrence) * Patients with breast cancer diagnosis during pregnancy (women who could bear children must have a negative pregnancy test before beginning this study) * Patients with documented sensitivity to gadolinium (contrast agent used during MRI) * Patients who weigh more than 350 pounds (weight limit on MRI machine) * Patients who receive neoadjuvant chemotherapy * Patients with renal insufficiency (serum Cr \> 1.5) due to the danger of nephrogenic systemic sclerosis with the administration of Gadolinium
References
Publications (0)
Data not yet available
No reference posted for this study.