Back to results68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
Primary Purpose
Prostate Cancer, Prostatic Neoplasm, Prostatic Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
[68Ga]Ga-HTK03149 PET/CT
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- BC Cancer
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[68Ga]Ga-HTK03149 PET/CT
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04831307
First Posted
April 1, 2021
Last Updated
December 1, 2021
Sponsor
British Columbia Cancer Agency
1. Study Identification
Unique Protocol Identification Number
NCT04831307
Brief Title
68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
Official Title
Evaluation of the in Vivo Biodistribution and Radiation Dosimetry of 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Neoplasm, Prostatic Disease, Urogenital Neoplasms, Disease Attributes, Neoplasms
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[68Ga]Ga-HTK03149 PET/CT
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
[68Ga]Ga-HTK03149 PET/CT
Intervention Description
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
Primary Outcome Measure Information:
Title
Biodistribution of 68Ga-HTK03149 PET/CT in human subjects
Description
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
Secondary Outcome Measure Information:
Title
Number of participants with 68Ga-HTK03149 related adverse events as assessed by abnormal vital sign measurement
Description
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
Title
Number of participants with self-reported 68Ga-HTK03149 related adverse event
Description
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
Title
Perform a preliminary assessment of 68Ga-HTK03149 uptake in prostate cancer lesions
Description
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
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
BC Cancer
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
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