Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer

March 3, 2016 updated by: Mary Mahoney, University of Cincinnati

Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer

The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See brief summary.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnnati, Ohio, United States, 45219
        • UC Hospital, The Barrett Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • subject is 25-100 years of age
  • subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
  • subject is able to provide informed consent

Exclusion Criteria:

  • subject is pregnant
  • subject is actively lactating or discontinued breastfeeding less than 2 months ago
  • subject has breast implants
  • subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study
  • subject has contraindications for core biopsy and other invasive procedures
  • subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus
  • subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months
  • subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEM Breast Biopsy
All patients underwent PEM biopsy.
Procedure: PEM Breast Biopsy
Breast biopsy using PEM guidance and Stereo Navigator software
Other Names:
  • Naviscan PEM 2400 Pet Scanner
  • Stereo Navigator Accessory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
Time Frame: At time of biopsy
At time of biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: Mary C Mahoney, MD, Univeristy of Cincinnati
  • Principal Investigator: Amy Argus, MD, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cincinnati-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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