PSMA-based 18F-DCFPyL PET/CT: Evaluating Its Application in Real Life (PEARL)
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|ClinicalTrials.gov Identifier: NCT03609736|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Diagnostic Test: 18F-DCFPyL PET/CT|
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Official Title:||PSMA-based 18F-DCFPyL PET/CT: Evaluating Its Application in Real Life|
|Actual Study Start Date :||August 10, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||December 2019|
- Diagnostic Test: 18F-DCFPyL PET/CT
- A bolus of less than or equal to 9 mCi (333 MBq) of 18F-DCFPyL will be injected IV by slow IV push.
- After administration of the 18F-DCFPyL the line will be flushed with saline (0.9% w/v).
- Subjects should be encouraged to drink up to 500 mL of water shortly after the administration of 18F-DCFPyL.
- At 60-minutes (± 10 minutes) after administration of 18F-DCFPyL, the PET/CT scan will be acquired with the subject in the supine position and the FOV including the mid-thighs to skull base.
- To acquire pilot data on the use of 18F-DCFPyL PET/CT following conventional imaging (CT and bone scan) for the detection of metastases in men with prostate cancer [ Time Frame: 1 year ]To acquire pilot data on the use of 18F-DCFPyL PET/CT following conventional imaging (CT and bone scan) for the detection of metastases in men with prostate cancer when: 1. The CT scan shows indeterminate lymph node(s) in the pelvis that could potentially be treated radically with radiotherapy if found to be positive on 18F-DCFPyL PET/CT; 2. The subject is suspected to have oligometastatic disease (< 4 sites of disease) that could potentially be treated with stereotactic/ radical doses of radiotherapy.
- To acquire pilot data comparing the number and location of metastatic lesions on 18F-DCFPyL PET/CT with standard of care imaging (CT and bone scan). [ Time Frame: 1 year ]
- To acquire pilot data on the change in management plans resulting from 18F-DCFPyL PET/CT compared with standard of care imaging (CT and bone scan). [ Time Frame: 1 year ]
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): NCT03609736
|Grand River Hospital||Recruiting|
|Kitchener, Ontario, Canada|
|Contact: Carla Girolametto 5197494370 ext 2307 firstname.lastname@example.org|