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

NCT ID: NCT00639535

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Disease

Keywords

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Radiology MRI Positron emission tomography Breast Abnormalities Dense Breast Tissue

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

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David Feiglin

Chairman Radiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Feiglin, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

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Central New York PET Center

Liverpool, New York, United States

Site Status

University Radiology Associates

Syracuse, New York, United States

Site Status

Institute For Human Performance

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SUNYUMU 4493

Identifier Type: -

Identifier Source: org_study_id