Study Comparing the PET Scan and MRI in Identifying Breast Malignancies in Women With Breast Abnormalities
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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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Contact: Susan Hemingway | 315-464-5099 | hemingws@upstate.edu |
| 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 | |
| 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 May 22, 2013