- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869335
A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
June 4, 2013 updated by: Roberto Agresti, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
260
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Milan, Italy, 20133
- Fondazione IRCCS Istituto Nazionale Dei Tumori
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: radiography
Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.
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Active Comparator: MRI (magnetic resonance imaging)
Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
May 24, 2013
First Submitted That Met QC Criteria
June 4, 2013
First Posted (Estimate)
June 5, 2013
Study Record Updates
Last Update Posted (Estimate)
June 5, 2013
Last Update Submitted That Met QC Criteria
June 4, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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