A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

260

Conditions

Breast Cancer

Interventions

radiographyDEVICE

MRI (magnetic resonance imaging)DEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Outcomes

Primary Outcomes

Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens

Diagnostic efficacy will be evaluated by statistical analysis

Time frame: 2 years

Central Contacts

Roberto Agresti, MD

CONTACT

+39 02 2390 roberto.agresti@istitutotumori.mi.it

Data from ClinicalTrials.gov

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