A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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radiography

Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.

Group Type ACTIVE_COMPARATOR

radiography

Intervention Type DEVICE

MRI (magnetic resonance imaging)

Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.

Group Type ACTIVE_COMPARATOR

MRI (magnetic resonance imaging)

Intervention Type DEVICE

Interventions

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radiography

Intervention Type DEVICE

MRI (magnetic resonance imaging)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No