A Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens

A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01869335

Enrollment

260

Registered

2013-06-05

Start date

2013-05-31

Completion date

2015-05-31

Last updated

2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, MRI, mammography, microcalcifications, Local staging of breast microcalcifications, Evaluation of ex vivo MRI for breast malignancies detected by MRI only

Brief 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.

Interventions

DEVICEradiography

DEVICEMRI (magnetic resonance imaging)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens	2 years	Diagnostic efficacy will be evaluated by statistical analysis

Countries

Italy

Contacts

Primary ContactRoberto Agresti, MD

roberto.agresti@istitutotumori.mi.it+39 02 2390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026