Breast Cancer
Conditions
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 (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.
Interventions
DEVICEPerformance 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
26 Years to No maximum
Healthy volunteers
No
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 score 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating Performance of the R-PEM system as the Dose Decays | 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. |
Countries
Canada
Outcome results
None listed