A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
Recruitment status was Not yet recruiting
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|