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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Performance of R-PEM | Experimental | 5mCi 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Performance of R-PEM | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivianne Freitas, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre, University Health Network, 610 University Ave. | Toronto | Ontario | M5G 2M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38334470 | Derived | Freitas V, Li X, Scaranelo A, Au F, Kulkarni S, Ghai S, Taeb S, Bubon O, Baldassi B, Komarov B, Parker S, Macsemchuk CA, Waterston M, Olsen KO, Reznik A. Breast Cancer Detection Using a Low-Dose Positron Emission Digital Mammography System. Radiol Imaging Cancer. 2024 Mar;6(2):e230020. doi: 10.1148/rycan.230020. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |