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Clinical Trial Summary

This is a preliminary evaluation of a radiotracer's biodistribution in human subjects. It is a prospective, single-centre, open-label, single group assignment interventional study. Prostate cancer is very common, and PSMA imaging is currently the most accurate means of localizing these tumours. The goal is to evaluate the biodistribution and safety of [68Ga]HTK03149 PET/CT for prostate cancer imaging.

Clinical Trial Description

Each subject will have a PET/CT scan using [68Ga]HTK03149 . The [68Ga]HTK03149 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. After providing informed written consent subjects will complete a medical history questionnaire. Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of [68Ga]HTK03149 . Eighteen to seventy-two hours after [68Ga]HTK03149 administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire. Follow-up Assessments The following information will be collected up to 12 months following the PET/CT scans: Initiation of a new treatment, Laboratory results and pathology reports, Results of imaging studies, Final clinical diagnosis by physician and relevant clinical notes. The study is expected to take up to 1 year for accrual. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04831307
Study type Interventional
Source British Columbia Cancer Agency
Status Not yet recruiting
Phase N/A
Start date June 2021
Completion date September 2022

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