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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: PEM Breast Biopsy

• Registration Number: NCT00981812
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Results First Submitted: 2014-12-23
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Results First Posted: 2016-04-04
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEM Breast Biopsy	PEM Breast Biopsy	All patients underwent PEM biopsy.

Primary Outcome Measures

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

Trial Locations

Locations (1)

UC Hospital, The Barrett Center; 🇺🇸 Cincinnnati, Ohio, United States