Trial Outcomes & Findings for Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer (NCT NCT00981812)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

At time of biopsy

Results posted on

2016-04-04

Recruited from 02/2010 to 06/2011 from University of Cincinnati Medical Center, Radiology Department, Breast Imaging.

Participant milestones
Measure	PEM Breast Biopsy PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Primary n=20 Participants Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

Timeframe: At time of biopsy

Outcome measures
Measure	Lesions Visualized Using Positron Emission Mammography (PEM) n=20 Participants Total lesions visualized using positron emission mammography.
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. Index Lesioins	22 Breast Lesions
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. Index Lesions Visualized at PEM	21 Breast Lesions
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. Additional Lesions seen only at PEM	6 Breast Lesions
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. Lesions technically adequate for targeting	26 Breast Lesions
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. Number of Lesions Biopsied	24 Breast Lesions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Cincinnati Medical Center

Phone: 513-584-4396