Clinical trial · Interventional
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
NCT02956473CI-TRIAL-00074913completedN/AResults postedClinicalTrials.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 research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mammography | Device | — | UNRESOLVED |
| Neoadjuvant Therapy (NAT) | Other | — | UNRESOLVED |
| Standard MRI | Device | — | UNRESOLVED |
| Standard of Care | Procedure | — | UNRESOLVED |
| Supine MRI | Device | — | UNRESOLVED |
| Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supine MRI
- description
- * Standard MRI will be performed * Supine MRI will be performed * Participant will receive mammography and ultrasound * Breast Radiologist will take a brief survey. * Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care * Standard of care will be performed
- interventionNames
- Device: Supine MRI
- Other: Neoadjuvant Therapy (NAT)
- Device: Ultrasound
- Device: Mammography
- Procedure: Standard of Care
- Device: Standard MRI
Primary outcomes (3)
- measure
- Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size
- timeFrame
- time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
- description
- Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must be female * Participants must have a pre-operative standard mammogram with or without ultrasound. * Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at (BWH, BWFH) * Patient must meet standard MRI guidelines and be able and willing to undergo MRI * Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for BCT, and the ability to undergo standard radiation therapy post-operatively). * Study participants will be restricted to those aged ≥18 years old. This age group is selected because it encompasses the majority of women likely to receive neoadjuvant therapy * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants with a known BRCA 1 or 2 mutation. * Participants with a known Li-Fraumeni or Cowden's Disease. * Participants with prior mantle radiation. * Participants with inflammatory breast cancer or multi-centric disease * Participants who are pregnant. * Participants who are already enrolled in a conflicting investigational trial * Participants with known active collagen vascular disease. * Participants with prior history of ipsilateral breast carcinoma treated with BCS and radiation therapy. * Patients who have biopsy confirmed multi-centric disease. * Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure * Participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the MRI scanner.
References
Publications (0)
Data not yet available
No reference posted for this study.