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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by State University of New York - Upstate Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00639535
First received: March 12, 2008
Last updated: April 26, 2011
Last verified: September 2009
  Purpose

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
Breast Abnormalities

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Estimated Enrollment: 100
Study Start Date: January 2002
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639535

Contacts
Contact: Susan Hemingway 315-464-5099 hemingws@upstate.edu

Locations
United States, New York
Central New York PET Center Recruiting
Liverpool, New York, United States, 13088
Contact: Susan Hemingway, CCRP    315-464-5099    hemingws@upstate.edu   
Principal Investigator: David Feiglin, MD         
Institute For Human Performance Recruiting
Syracuse, New York, United States, 13210
Contact: Susan Hemingway, CCRP    315-464-5099      
Principal Investigator: David Feiglin, MD         
University Radiology Associates Recruiting
Syracuse, New York, United States, 13202
Contact: Susan Hemingway, CCRP    315-464-5099    hemingws@upstate.edu   
Principal Investigator: David Feiglin, MD         
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: David Feiglin, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: David Feiglin, MD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00639535     History of Changes
Other Study ID Numbers: SUNYUMU 4493
Study First Received: March 12, 2008
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Radiology
MRI
Positron emission tomography
Breast Abnormalities
Dense Breast Tissue

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 30, 2014