Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Information provided by (Responsible Party):
Roberto Agresti, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Identifier:
First received: May 24, 2013
Last updated: June 4, 2013
Last verified: May 2013

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.

Condition Intervention
Breast Cancer
Device: radiography
Device: MRI (magnetic resonance imaging)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications

Resource links provided by NLM:

Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Diagnostic efficacy will be evaluated by statistical analysis

Estimated Enrollment: 260
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: radiography
Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.
Device: radiography
Active Comparator: MRI (magnetic resonance imaging)
Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
Device: MRI (magnetic resonance imaging)


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01869335

Contact: Roberto Agresti, MD +39 02 2390 ext 2168

Fondazione IRCCS Istituto Nazionale dei Tumori Not yet recruiting
Milan, Italy, 20133
Contact: Roberto Agresti, MD    +39 022390 ext 2168   
Principal Investigator: Roberto Agresti, MD         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  More Information

Responsible Party: Roberto Agresti, MD, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Identifier: NCT01869335     History of Changes
Other Study ID Numbers: 15/13
Study First Received: May 24, 2013
Last Updated: June 4, 2013
Health Authority: Italy: National Institute of Health

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
breast cancer
Local staging of breast microcalcifications
Evaluation of ex vivo MRI for breast malignancies detected by MRI only processed this record on February 27, 2015