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

This study is currently recruiting participants.
Verified September 2009 by State University of New York - Upstate Medical University
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

March 12, 2008
April 26, 2011
January 2002
January 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00639535 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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

Breast Abnormalities
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2014
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Susan Hemingway 315-464-5099 hemingws@upstate.edu
United States
 
NCT00639535
SUNYUMU 4493
No
David Feiglin, MD, SUNY Upstate Medical University
State University of New York - Upstate Medical University
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Principal Investigator: David Feiglin, MD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP