68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer, Prostatic Neoplasm, Prostatic Disease, Urogenital Neoplasms, Disease Attributes, Neoplasms

Intervention / Treatment
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* Other: [68Ga]Ga-HTK03149 PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with newly diagnosed or documented prostate cancers (PCa), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-DCFPyL or 68Ga-PSMA-11 PET). ECOG performance status of 2 or less. Exclusion Criteria: Medically unstable (eg. acute illness, unstable vital signs) Unable to lie supine for the duration of imaging Unable to provide written consent Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm) Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes. Patients with baseline ALT or AST higher than 5× ULN or 250 U/L. Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR >1.2, or platelet count below the lower limit of normal (typically <150 000/μL. Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [68Ga]Ga-HTK03149 PET/CT<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to 12 months |