Back to resultsA Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
radiography
MRI (magnetic resonance imaging)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, MRI, mammography, microcalcifications, Local staging of breast microcalcifications, Evaluation of ex vivo MRI for breast malignancies detected by MRI only
Eligibility 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
Sites / Locations
- Fondazione IRCCS Istituto Nazionale dei Tumori
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
radiography
MRI (magnetic resonance imaging)
Arm Description
Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.
Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01869335
First Posted
May 24, 2013
Last Updated
June 4, 2013
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1. Study Identification
Unique Protocol Identification Number
NCT01869335
Brief Title
A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
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 Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, MRI, mammography, microcalcifications, Local staging of breast microcalcifications, Evaluation of ex vivo MRI for breast malignancies detected by MRI only
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiography
Arm Type
Active Comparator
Arm Description
Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.
Arm Title
MRI (magnetic resonance imaging)
Arm Type
Active Comparator
Arm Description
Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
Intervention Type
Device
Intervention Name(s)
radiography
Intervention Type
Device
Intervention Name(s)
MRI (magnetic resonance imaging)
Primary Outcome Measure Information:
Title
Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens
Description
Diagnostic efficacy will be evaluated by statistical analysis
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Agresti, MD
Phone
+39 02 2390
Ext
2168
Email
roberto.agresti@istitutotumori.mi.it
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Agresti, MD
Phone
+39 022390
Ext
2168
Email
roberto.agresti@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Roberto Agresti, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
20652399
Citation
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.
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A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
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