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

NCT00639535 | Completed

• 1 other identifier: SUNYUMU 4493
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Disease

Keywords

Radiology; MRI; Positron emission tomography; Breast Abnormalities; Dense Breast Tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (3)

Central New York PET Center

Liverpool, New York, 13088, United States

Location

University Radiology Associates

Syracuse, New York, 13202, United States

Location

Institute For Human Performance

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Feiglin, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Radiology Department

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 20, 2008
• Study Start: January 1, 2002
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

US (3)