NCT04831307

68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical

Evaluation of the in Vivo Biodistribution and Radiation Dosimetry of 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Cancer
• Prostatic Neoplasm
• Prostatic Disease
• Urogenital Neoplasms
• Disease Attributes
• Neoplasms

Interventions

Type	Name	Description
OTHER	[68Ga]Ga-HTK03149 PET/CT	200 MBq/m2 of body surface area, with a 200 MBq minimum adult administered activity will be injected intravenously prior to perform the PET/CT

Timeline

• Start date: 2021-08-30
• Primary completion: 2021-12-01
• Completion: 2022-08-01
• First posted: 2021-04-05
• Last updated: 2021-12-03

Locations

1 site across 1 country: Canada