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

NCT ID: NCT00981812

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-04-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PEM Breast Biopsy

All patients underwent PEM biopsy.

Group Type: EXPERIMENTAL

PEM Breast Biopsy

Intervention Type: PROCEDURE

Breast biopsy using PEM guidance and Stereo Navigator software

Interventions

PEM Breast Biopsy

Breast biopsy using PEM guidance and Stereo Navigator software

Intervention Type: PROCEDURE

Other Intervention Names

Naviscan PEM 2400 Pet Scanner; Stereo Navigator Accessory

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Mary Mahoney

Professor, Director of Breast Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary C Mahoney, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Cincinnati

Amy Argus, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

UC Hospital, The Barrett Center

Cincinnnati, Ohio, United States

Countries

United States

Other Identifiers

Cincinnati-01

Identifier Type: -

Identifier Source: org_study_id