Clinical trial · Interventional
Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy
Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accural
Summary
Brief summary (as posted)
This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.
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 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MRI
- description
- MRI
- interventionNames
- Other: MRI
- type
- NO_INTERVENTION
- label
- No MRI
- description
- No MRI
Primary outcomes (1)
- measure
- Assess if pre-operative MRI reduces incidence of re-excisions required
- timeFrame
- 2 years
- description
- Assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must undergo definitive local therapy with either breast conserving therapy or mastectomy * Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative * Able to undergo breast MRI Exclusion Criteria: * Not pregnant or breastfeeding * No prior breast MRI for the newly diagnosed carcinoma at the outside hospital * No prior mantle radiation * No locally advanced breast cancer * No diffuse malignant appearing microcalcifications requiring mastectomy * No known collagen vascular disease * No previous ipsilateral radiation * No participants who undergo surgery at an outside institution * No prior history of breast carcinoma
References
Publications (0)
Data not yet available