A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: MRI (magnetic resonance imaging); Device: radiography

Study type: Interventional

Funder types: Other

Identifiers

NCT01869335

15/13

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

radiography

Active Comparator group

Description:

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

Treatment:

Device: radiography

MRI (magnetic resonance imaging)

Active Comparator group

Description:

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

Treatment:

Device: MRI (magnetic resonance imaging)