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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639535
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : May 21, 2015
Information provided by (Responsible Party):
David Feiglin, State University of New York - Upstate Medical University

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.

Condition or disease
Breast Disease

Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : January 2002
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from Breast Care Clinic and local physicians.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639535

United States, New York
Central New York PET Center
Liverpool, New York, United States, 13088
University Radiology Associates
Syracuse, New York, United States, 13202
Institute For Human Performance
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Principal Investigator: David Feiglin, MD State University of New York - Upstate Medical University

Responsible Party: David Feiglin, Chairman Radiology Department, State University of New York - Upstate Medical University Identifier: NCT00639535     History of Changes
Other Study ID Numbers: SUNYUMU 4493
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by David Feiglin, State University of New York - Upstate Medical University:
Positron emission tomography
Breast Abnormalities
Dense Breast Tissue

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Diseases
Skin Diseases