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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PEM Breast Biopsy

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring PET, PEM, Positron Emission Mammography, Breast Biopsy

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

UC Hospital, The Barrett Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEM Breast Biopsy

Arm Description

All patients underwent PEM biopsy.

Outcomes

Primary Outcome Measures

Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.

Secondary Outcome Measures

Full Information

NCT ID

NCT00981812

First Posted

September 18, 2009

Last Updated

March 3, 2016

Sponsor

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT00981812

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cincinnati

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

See brief summary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

PET, PEM, Positron Emission Mammography, Breast Biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PEM Breast Biopsy

Arm Type

Experimental

Arm Description

All patients underwent PEM biopsy.

Intervention Type

Procedure

Intervention Name(s)

PEM Breast Biopsy

Other Intervention Name(s)

Naviscan PEM 2400 Pet Scanner, Stereo Navigator Accessory

Intervention Description

Breast biopsy using PEM guidance and Stereo Navigator software

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary C Mahoney, MD

Organizational Affiliation

Univeristy of Cincinnati

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amy Argus, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Hospital, The Barrett Center

City

Cincinnnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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