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

Breast Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639535
• Other study ID #: SUNYUMU 4493
• Status: Completed
• Start date: January 2002
• Est. completion date: April 2014

Study information

• Verified date: December 2023
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Disease
• Breast Diseases
• Congenital Abnormalities

Locations

Country	Name	City	State
United States	Central New York PET Center	Liverpool	New York
United States	Institute For Human Performance	Syracuse	New York
United States	University Radiology Associates	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States,