A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications
1 other identifier
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 5, 2013
May 1, 2013
1.6 years
May 24, 2013
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Study Arms (2)
radiography
ACTIVE COMPARATORArm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.
MRI (magnetic resonance imaging)
ACTIVE COMPARATORArm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
Interventions
Eligibility Criteria
You may qualify if:
- Women with malignant breast disease identified by microcalcifications without clinically evident disease
- Women candidate to breast preserving surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Related Publications (1)
Elshof LE, Rutgers EJ, Deurloo EE, Loo CE, Wesseling J, Pengel KE, Gilhuijs KG. A practical approach to manage additional lesions at preoperative breast MRI in patients eligible for breast conserving therapy: results. Breast Cancer Res Treat. 2010 Dec;124(3):707-15. doi: 10.1007/s10549-010-1064-z. Epub 2010 Jul 22.
PMID: 20652399BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 24, 2013
First Posted
June 5, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2014
Study Completion
May 1, 2015
Last Updated
June 5, 2013
Record last verified: 2013-05