A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01869335
• Other study ID #: 15/13
• Status: Not yet recruiting
• Phase: N/A
• First received: May 24, 2013
• Last updated: June 4, 2013
• Start date: May 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2013
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: Roberto Agresti, MD
• Phone: +39 02 2390
• Email: roberto.agresti[@]istitutotumori.mi.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• radiography

• MRI (magnetic resonance imaging)

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No