68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical

Summary

Participation Requirements

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...

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.

Tracking Information