A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
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 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|
- 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
|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)|
Active Comparator: radiography
Arm1: patients undergo mammographic localizations and radiography of the specimen after surgical resection.
Active Comparator: MRI (magnetic resonance imaging)
Arm2: patients undergo MRI localization and ex vivo MRI after surgical resection.
|Device: MRI (magnetic resonance imaging)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869335
|Contact: Roberto Agresti, MD||+39 02 2390 ext firstname.lastname@example.org|
|Fondazione IRCCS Istituto Nazionale dei Tumori||Not yet recruiting|
|Milan, Italy, 20133|
|Contact: Roberto Agresti, MD +39 022390 ext 2168 email@example.com|
|Principal Investigator: Roberto Agresti, MD|