NCT03520218

Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 26 Years
• Healthy volunteers: Not accepted

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 (millicurie) of F18-Fluorodeoxyglucose (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 Magnetic Resonance Imaging (MRI) and digital breast tomosynthesis (DBT) to study extension of disease and screening of contralateral breast.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Performance of R-PEM	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.

Timeline

• Start date: 2019-12-17
• Primary completion: 2022-11-03
• Completion: 2023-11-03
• First posted: 2018-05-09
• Last updated: 2024-07-17

Locations

1 site across 1 country: Canada