A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: MRI (magnetic resonance imaging); Device: radiography

• Registration Number: NCT01869335
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-05
• Last Update Posted: 2013-06-05
• Primary Completion: 2014-12
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MRI (magnetic resonance imaging)	MRI (magnetic resonance imaging)	Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
radiography	radiography	Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens	2 years	Diagnostic efficacy will be evaluated by statistical analysis

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy