An interventional study of [68Ga]Ga-HTK03149 PET/CT in Prostate Cancer, Prostatic Neoplasm and Prostatic Disease, sponsored by British Columbia Cancer Agency. Status unknown at 1 site in Canada. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-03.
Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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
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
Biodistribution of 68Ga-HTK03149 PET/CT in human subjects
Evaluate the biodistribution of 68Ga-HTK03149 in human subjects, which will enable calculating the radiation dosimetry of this radiopharmaceutical. The efficacy parameters will be the following: Individual organ dose and effective dose measured in mSV/MBq. Descriptive statistics on normal organ and tumour uptake reported in standardized uptake values (SUV). Tumour/blood, tumour/liver, tumour/kidney and tumour/lung ratios will be reported.
Time frame: Up to 12 months
Number of participants with 68Ga-HTK03149 related adverse events as assessed by abnormal vital sign measurement
Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at four time points. All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.
Time frame: Before injection, 1 hours post injection, 2 hours post injection and 2.5 hours post injection
Number of participants with self-reported 68Ga-HTK03149 related adverse event
Patients will return to the department 18-72 hours after the 68Ga-HTK03149 PET/CT scan to see if they experienced any adverse events. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.
Time frame: 18-72 hours
Perform a preliminary assessment of 68Ga-HTK03149 uptake in prostate cancer lesions
Determination of tumour uptake will be performed by contouring the tumours using a threshold to match the size of the lesion on CT imaging. The standardized uptake value (SUV) will be calculated and normalized for both body weight and lean body mass (SUVlean). The maximal, mean and peak (activity in the highest 1 cc voxel cluster) will be determined and recorded. The tumour/blood, tumour/liver and tumour/lung ratios will be reported for descriptive analysis.
Time frame: Up to 12 months
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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British Columbia Cancer Agency