Prostate Cancer
Conditions
Keywords
Prostate Cancer, PSMA PET Scan, Dynamic PET Scan
Brief summary
The goal of this study is to evaluate the imaging capabilities of a new prostate-targeted PET system (P-PET) and determine whether it could be useful in detecting prostate cancer by comparing SOC whole body PET imaging. This pilot study will include adult men who have been diagnosed with or are suspected to have prostate cancer. Participants will undergo a standard-of-care PET/CT scan followed by an additional P-PET scan designed to provide detailed images of the prostate. The images from the two scans to assess how well the P-PET system can detect prostate cancer.
Detailed description
This pilot study will evaluate the performance of a novel prostate-targeted positron emission tomography (PET) imaging system (P-PET) in men undergoing PET imaging for primary staging of prostate cancer. This study is designed to assess the feasibility and diagnostic performance of this new imaging approach. Participants will receive the standard-of-care PET radiotracer fluroine-18 PSMA-1007 (18F-PSMA-1007) as part of routine clinical PET imaging. While the tracer is circulating in the body, a research dynamic imaging sequence will be performed, followed by the standard-of-care whole body PET scan. Immediately after completion of the standard imaging, participants will undergo the research P-PET scan during the same imaging visit. No additional radiotracer will be administered for the P-PET scan, as it used the same tracer injection given for the standard-of-care PET imaging. Images obtained from the P-PET system will undergo comparative analysis with the standard-of-care PET scan images to assess lesion detection, image quality and overall imaging performance. The findings from this study will provide preliminary data on feasibility and potential diagnostic value of the P-PET system and may guide future research in prostate-targeted PET imaging.
Interventions
DIAGNOSTIC_TESTProstate-Targeted PET- Scan (P-PET).
Participants will undergo a prostate-targeted PET scan to detect prostate cancer. This research scan is performed after the standard-of-care PET scan to evaluate its imaging capability. While the radioisotope is still active.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is an open-label study. Both participants and study staff will know that all participants are receiving clinical PSMA PET/CT, research dynamic PET, and research P-PET scans.
Intervention model description
All participants will first be injected with the PET radiotracer 18F-PSMA-1007. Following tracer injection, a research dynamic imaging sequence will be performed, followed by the SOC whole body PET scan. After completion of the SOC imaging, participants will undergo an additional prostate-targeted P-PET scan during the same imaging visits. This single-group design allows images from the research P-PET system to be compared with those for the standard-of-care PET scan with the same participant.
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Qualitative comparison of PET scans acquired by the P-PET vs. WB PET
Exclusion criteria
* Unable to comply with the length of scan time due to the study imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative comparison of PET scans acquired by the P-PET vs. WB PET | Baseline (Day1) | The primary outcome is the detection of prostate cancer lesions by the research prostate-targeted P-PET scan. Images from the P-PET scan will be compared to standard-of-care PET scan images to evaluate the sensitivity and clarity of the new imaging system in identifying cancerous lesions in the prostate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Prostate Lesions Detected by P-PET Compared with Standard-of-care Whole-Body PET | Baseline (Day 1) | The number of pelvic lesions detected by P-PET in comparison with the number of lesions detected by standard-of-care whole body PET/CT. |
Countries
Canada
Contacts
CONTACTMaureen Dougan
CONTACTStephen Pautler, BSc MD FRCSC
PRINCIPAL_INVESTIGATORStephen Pautler, BSc MD FRCSC
St. Joseph Health Care London
Outcome results
None listed