Clinical trial · Interventional
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
NCT02335671CI-TRIAL-00064299completedN/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)
The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.
Conditions
Conditions (3)
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 Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative Magnetic Resonance Imaging (MRI) | Procedure | — | UNRESOLVED |
| Mass Spectrometer Analysis of Tissue Sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intra-operative Magnetic Resonance Imaging (MRI)
- description
- * Preoperative diagnostic MRI * Intra-operative MRI * Standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated * Specimen to Pathology and Mass Spectrometer (Analysis of Tissue Sample)
- interventionNames
- Procedure: Intra-operative Magnetic Resonance Imaging (MRI)
- Other: Mass Spectrometer Analysis of Tissue Sample
Primary outcomes (1)
- measure
- To evaluate the accuracy of MRI in detecting tumor boundaries
- timeFrame
- 2 Years
Secondary outcomes (3)
- measure
- To determine the operating characteristics (sensitivity, specificity, negative predictive value and positive predictive value) of MRI in detecting tumor boundaries as confirmed with pathologic results
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be female * Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions. * Participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI. * Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively). * Patient must meet standard MRI guidelines and be able and willing to undergo MRI * Age ≥18 years and \< 75. * 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 known Li-Fraumeni or Cowden's Disease. * Participants with prior mantle radiation. * Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin. * Participants who are pregnant. * Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy. * Participants with known active collagen vascular disease. * Participants with prior history of ipsilateral breast carcinoma. * Patients who have biopsy confirmed multi-centric disease. * Participants who have documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure. * Participants who exceed the weight limit for the surgical table at AMIGO, 350 lbs or who will not fit into the 70 cm diameter bore of the MRI scanner at AMIGO or the 60 cm diameter bore of the pre-procedure imaging MRI scanner.
References
Publications (0)
Data not yet available
No reference posted for this study.