A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications
N/A
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens
Outcome Description:
Diagnostic efficacy will be evaluated by statistical analysis
Outcome Time Frame:
2 years
Safety Issue:
No
Authority:
Italy: National Institute of Health
Study ID:
15/13
NCT ID:
NCT01869335
Start Date:
May 2013
Completion Date:
May 2015
Related Keywords:
- Breast Cancer
- breast cancer
- MRI
- mammography
- microcalcifications
- Local staging of breast microcalcifications
- Evaluation of ex vivo MRI for breast malignancies detected by MRI only
- Breast Neoplasms
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