Clinical trial · Interventional
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study in Patients With Prostate Cancer
NCT06612580CI-TRIAL-00081059recruitingEarly Phase 1ClinicalTrials.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)
68Ga-AAZTA-093 is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-AAZTA-NI-093 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-AAZTA-NI-093 PET/ CT
- description
- 68Ga-AAZTA-NI-093 Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-NI-093. Tracer doses of 68Ga-AAZTA-NI-093 will be used to image lesions of prostate cancer by PET/CT
- interventionNames
- Drug: 68Ga-AAZTA-NI-093
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- Within 7 days following PET/CT
- description
- The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Secondary outcomes (1)
- measure
- Dosimetry data
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed treated or untreated prostate cancer patients; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.