Study Comparing the PET Scan and MRI in Identifying Breast Malignancies in Women With Breast Abnormalities

Comparative Study of the Diagnostic Accuracy of Scintimammography (Fluorine 18-FDG PET Scintigraphic Imaging) and Magnetic Resonance Imaging in Identifying Malignant Breast Lesions, In Subjects With Breast Abnormalities

This is a study looking at advanced imaging such as PET/CT and MRI to see if they can provide a more accurate assessment of the patient with dense breasts or difficult to interpret mammograms. In addition, the ability to determine whether one or the other is more accurate or whether both together would be appropriate in this clinical situation, may be able to be measured.

The MRI studies are very sensitive for detection of breast histopathology but less specific in differentiating between small low grade malignancies are more benign pathologies. Multifocal pathology can be challenging in determining site(s) for biopsy.

PET scanning is specific in the measurement of metabolic glucose activity of various histopathologies and is accurate in differentiating aggressive from benign pathology in multifocal breast disease. A further drawback of PET is the lack of ability to observe lesions less than 3-4mm in diameter.

In select cases the combination of MR and PET/CT is able to come to a more conclusive diagnosis - specifically with bilateral or multifocal breast disease.

Study Overview

• Status: Completed
• Conditions: Breast Disease

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United States
  • New York
    • Liverpool, New York, United States, 13088
      • Central New York PET Center
    • Syracuse, New York, United States, 13202
      • University Radiology Associates
    • Syracuse, New York, United States, 13210
      • Institute For Human Performance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from Breast Care Clinic and local physicians.

Description

Inclusion Criteria:

• Woman who have breast volumes allowing utilization of MRI breast coil
• Patients who are considered, by radiologist reading the mammograms, to have non interpretable or difficult to interpret x-ray studies. These patients may or may not have palpable breast lumps and may and may not have suspicious areas on their x-ray mammograms.

Exclusion Criteria:

• Women of child bearing potential not practicing a medically accepted method of birth control
• Women who are pregnant or breast-feeding

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: David Feiglin, MD, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2002
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 12, 2008
• First Submitted That Met QC Criteria: March 19, 2008
• First Posted (Estimated): March 20, 2008

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Radiology; Dense Breast Tissue; Positron emission tomography; Breast Abnormalities
• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Breast Diseases
• Other Study ID Numbers: SUNYUMU 4493