Clinical trial · Interventional
A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications
- 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)
Radiography of breast specimens is currently the only radiological procedure used to verify removal of microcalcifications and presence of tumor-free margins after breast surgical resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not detected by radiography in resected breast tumor specimens and/or its ability to verify tumor-free margins in breast cancer detected by MRI only.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI (magnetic resonance imaging) | Device | — | UNRESOLVED |
| radiography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- radiography
- description
- Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.
- interventionNames
- Device: radiography
- type
- ACTIVE_COMPARATOR
- label
- MRI (magnetic resonance imaging)
- description
- Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
- interventionNames
- Device: MRI (magnetic resonance imaging)
Primary outcomes (1)
- measure
- Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women with malignant breast disease identified by microcalcifications without clinically evident disease * Women candidate to breast preserving surgery Exclusion Criteria: * Cardiac pacemaker, defibrillators, cardiac monitors * Brain stimulators, implantable spinal stimulators * Vascular and aneurismal clips * Hemostatic clips * Infusion pumps * Glaucoma drainage implants * Metallic foreign body positioned in vital organ of the patients * Some heart valves * Some vascular access ports, infusion pumps and catheters * Permanent contraceptive tubal device * Kidney disease
References
Publications (1)
- BACKGROUNDElshof LE, Rutgers EJ, Deurloo EE, Loo CE, Wesseling J, Pengel KE, Gilhuijs KG. A practical approach to manage additional lesions at preoperative breast MRI in patients eligible for breast conserving therapy: results. Breast Cancer Res Treat. 2010 Dec;124(3):707-15. doi: 10.1007/s10549-010-1064-z. Epub 2010 Jul 22. PMID 20652399