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A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

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ClinicalTrials.gov Identifier: NCT01869335
Recruitment Status : Unknown
Verified May 2013 by Roberto Agresti, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Not yet recruiting
First Posted : June 5, 2013
Last Update Posted : June 5, 2013
Sponsor:
Information provided by (Responsible Party):
Roberto Agresti, MD, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: radiography Device: MRI (magnetic resonance imaging) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens [ Time Frame: 2 years ]
    Diagnostic efficacy will be evaluated by statistical analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869335


Contacts
Contact: Roberto Agresti, MD +39 02 2390 ext 2168 roberto.agresti@istitutotumori.mi.it

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Not yet recruiting
Milan, Italy, 20133
Contact: Roberto Agresti, MD    +39 022390 ext 2168    roberto.agresti@istitutotumori.mi.it   
Principal Investigator: Roberto Agresti, MD         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Publications:
Responsible Party: Roberto Agresti, MD, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01869335     History of Changes
Other Study ID Numbers: 15/13
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: May 2013

Keywords provided by Roberto Agresti, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
breast cancer
MRI
mammography
microcalcifications
Local staging of breast microcalcifications
Evaluation of ex vivo MRI for breast malignancies detected by MRI only

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases