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Evaluation of the in Vivo Biodistribution and Radiation Dosimetry of 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
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.
Details
| Lead sponsor | British Columbia Cancer Agency |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 10 |
| Start date | 2021-08-30 |
| Completion | 2022-08 |
Conditions
- Prostate Cancer
- Prostatic Neoplasm
- Prostatic Disease
- Urogenital Neoplasms
- Disease Attributes
- Neoplasms
Interventions
- [68Ga]Ga-HTK03149 PET/CT
Primary outcomes
- Biodistribution of 68Ga-HTK03149 PET/CT in human subjects — Up to 12 months
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.
Countries
Canada