Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot project is to test the new Radialis Positron Emission Mammography (R-PEM) system in breast cancer patients that has a higher sensitivity with lower radiation doses than conventional PET/CT. The plan for the pilot study is to image patients who are already scheduled for diagnostic imaging for breast cancer after a positive core biopsy. Participants will be injected with 5mCi of F-18 FDG and patient will wait for a couple of hours for uptake of FDG. After this time, the first R-PEM scan will occur. Additional optional R-PEM scans can be performed 4 hours after injection and 7 hours after injection with reductions in radiation emission. Additionally, R-PEM images will be compared to standard-of-care breast MRI and digital breast tomosynthesis to study extension of disease and screening of contralateral breast.

Official Title
-----------------
A Pilot Study to Evaluate Low-Dose Positron Emission Mammography Imaging in Visualization and Characterization of Suspicious Breast Abnormalities

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Performance of R-PEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female of any race and ethnicity Subject is at least 26 years old Following routine mammography imaging, subject is categorized as BI-RADS® 4C or 5 because of calcifications, masses, asymmetries or/and architectural distortion will undergo additional tests including biopsy within 30 days of routine imaging Subject is female with a recent breast biopsy confirming breast cancer Exclusion Criteria: Subject unable or unwilling to undergo informed consent Subjects who are unable or unwilling to tolerate any of the imaging tests because of claustrophobia, compression, etc. Subjects who are pregnant or who think they may be pregnant Subjects who are breast-feeding Subjects weight exceed table limits of MRI and PET-CT (300-450 lb or 135-205 kg) Subjects with history of allergic reaction to gadolinium or previous history of life-threatening anaphylactic reaction to any contrast. Claustrophobic subjects

Ages Eligible for Study
-----------------
Minimum Age: 26 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Performance of R-PEM<br>5miCi of F-18 FDG will be injected and patients will wait for uptake of FDG before proceeding with first set of R-PEM scans. Additional optional R-PEM scans may be performed 4 hours after injection, and then possibly 7 hours after injection. These R-PEM images will be compared to standard diagnostic breast work-up using DBT and MRI | Device: Performance of R-PEM<br>* R-PEM imaging will produce high-sensitivity images with low levels of F-18 FDG and optional subsequent scans performed will display reduced levels of the injected radiotracer.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating Performance of the R-PEM system as the Dose Decays | The diagnostic performance of R-PEM including sensitivity, specificity, positive and negative predictive values compared to magnetic resonance imaging, digital breast tomosynthesis mammography, and digital mammography in characterization of suspicious breast abnormalities will also be evaluated in our study when those images are available through standard patient care. | 2 years |