A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens
Conditions
Breast Cancer
Conditions: Keywords
breast cancer, MRI, mammography, microcalcifications, Local staging of breast microcalcifications, Evaluation of ex vivo MRI for breast malignancies detected by MRI only
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: radiography Type: Device
Name: MRI (magnetic resonance imaging) Type: Device
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
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
Location
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Status: Not yet recruiting
Contact: Roberto Agresti, MD - +39 022390 - roberto.agresti@istitutotumori.mi.it
Start Date
May 2013
Completion Date
May 2015
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Source
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page