Evaluating Positron Emission Mammography Imaging of Suspicious Breast Abnormalities
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|ClinicalTrials.gov Identifier: NCT03520218|
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : September 30, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Performance of R-PEM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate Low-Dose Positron Emission Mammography Imaging in Visualization and Characterization of Suspicious Breast Abnormalities|
|Actual Study Start Date :||December 17, 2019|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Experimental: Performance of R-PEM
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
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.
- Evaluating Performance of the R-PEM system as the Dose Decays [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520218
|Contact: Anabel Scaranelo||416 946-4501 ext firstname.lastname@example.org|
|Princess Margaret Cancer Centre, University Health Network, 610 University Ave.||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Anabel Scaranelo Anabel.Scaranelo@uhn.ca|
|Principal Investigator: Anabel Scaranelo|
|Principal Investigator:||Anabel Scaranelo||University Health Network, Toronto|