Prostate CancerNCT04831307
68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
A study testing [68Ga]Ga-HTK03149 PET/CT in people with Prostate Cancer and Prostatic Neoplasm, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasm, Prostatic Disease
- What is being tested?
- [68Ga]Ga-HTK03149 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2021to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Prostatic Neoplasm, Prostatic Disease, Urogenital Neoplasms, Disease Attributes, Neoplasms
- Being tested
- [68Ga]Ga-HTK03149 PET/CT
- Medical subject headings
- Prostatic Neoplasms, Prostatic Diseases, Urogenital Neoplasms, Disease Attributes, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-HTK03149 PET/CTOther
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
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-HTK03149 PET/CT | Experimental | 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 Receives: Other: [68Ga]Ga-HTK03149 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Aug 2021
- Primary completion1 Dec 2021
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831307
- Sponsor's protocol ID
- H21-00749
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chausse G, Hou X, Uribe C, Harsini S, Pan J, Saprunoff H, Allan H, Kuo HT, Lin KS, Wilson D, Benard F. First-in-Human Evaluation of [68Ga]Ga-HTK03149, a PSMA-Targeted Tracer for PET Imaging in Prostate Cancer. J Nucl Med. 2026 May 1;67(5):717-723. doi: 10.2967/jnumed.123.266357.
PubMed 41748290
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the in Vivo Biodistribution and Radiation Dosimetry of 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
- ClinicalTrials.gov ID
- NCT04831307
- Acronym / sponsor ID
- H21-00749
- Conditions
- Prostate Cancer, Prostatic Neoplasm, Prostatic Disease, Urogenital Neoplasms, Disease Attributes, Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- Aug 2022 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-HTK03149 PET/CT | Experimental | Other: [68Ga]Ga-HTK03149 PET/CT200 MBq/m2 of body surface area, with a 200 MBq minimum adult administered activity will be injected intravenously prior to perform the PET/CT |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-HTK03149 PET/CT200 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 |
Primary outcome
Biodistribution of 68Ga-HTK03149 PET/CT in human subjects
Time frame: 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.
3 secondary outcomes
Number of participants with 68Ga-HTK03149 related adverse events as assessed by abnormal vital sign measurement
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
Time frame: 18-72 hours
Perform a preliminary assessment of 68Ga-HTK03149 uptake in prostate cancer lesions
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Derived from this study: PubMed 41748290Chausse G, Hou X, Uribe C, Harsini S, Pan J, Saprunoff H, Allan H, Kuo HT, Lin KS, Wilson D, Benard F. First-in-Human Evaluation of [68Ga]Ga-HTK03149, a PSMA-Targeted Tracer for PET Imaging in Prostate Cancer. J Nucl Med. 2026 May 1;67(5):717-723. doi: 10.2967/jnumed.123.266357.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-HTK03149 PET/CT in people with Prostate Cancer and Prostatic Neoplasm, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of 68Ga-HTK03149 PET/CT in human subjects (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.