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Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities

NCT00606931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2009-07-07

Study results available
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Summary

The purpose of this pilot clinical study is to test a methodology for using high-resolution Positron Emission Tomography (PET) imaging to guide vacuum-assisted core biopsy of breast abnormalities identified on PET. In order to implement the PET guidance, the study uses the Stereo Navigator accessory to the high-resolution organ-specific PET scanner (PEM Flex™ PET Scanner, Naviscan PET Systems, Inc., San Diego, CA). The Stereo Navigator is an investigational device intended for guiding biopsy needles toward lesions in breasts identified by a physician on a high resolution PET image. The study will evaluate the clinical utility of the Stereo Navigator in guiding the vacuum-assisted core biopsy of breast abnormalities, following the example of prior studies of breast biopsy guided by magnetic resonance imaging (MRI)

Conditions

Interventions

DEVICE

Stereo Navigator Accessory to PEM Flex PET Scanner

For patients with suspicious breast abnormalities seen on high resolution PET image, the patients will be biopsied using commercial vacuum biopsy devices (pre-validated to work with Stereo Navigator) using Naviscan's Stereo Navigator (interventional device) for PET image guidance.

Sponsors & Collaborators

  • American Radiology Services, Inc

    collaborator OTHER

  • Boca Raton community Hospital, FL

    collaborator UNKNOWN

  • Diversified Specialty Institutes, Bensalem, PA

    collaborator UNKNOWN

  • Advanced Breast Care Imaging

    collaborator INDUSTRY

  • Epic Imaging

    collaborator INDUSTRY

  • Naviscan PET Systems

    lead INDUSTRY

Principal Investigators

  • Judith E Kalinyak, MD, Ph.D · Naviscan PET Systems, Inc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00606931 on ClinicalTrials.gov