Clinical trial · Interventional
68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
Evaluation of the in Vivo Biodistribution and Radiation Dosimetry of 68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical
NCT04831307CI-TRIAL-00055360unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease Attributes | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Disease | — | UNRESOLVED | — |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
| Urogenital Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-HTK03149 PET/CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-HTK03149 PET/CT
- 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
- interventionNames
- Other: [68Ga]Ga-HTK03149 PET/CT
Primary outcomes (1)
- measure
- Biodistribution of 68Ga-HTK03149 PET/CT in human subjects
- timeFrame
- Up to 12 months
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDChausse 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. PMID 41748290