Status:
UNKNOWN
68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Prostate Cancer
Prostatic Neoplasm
Eligibility:
MALE
18-100 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04831307
Start Date
August 30 2021
End Date
August 1 2022
Last Update
December 3 2021
Active Locations (1)
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1
BC Cancer
Vancouver, British Columbia, Canada, V5Z 4E6