Trials / Recruiting
RecruitingNCT06437496
68Ga-AAZTA-093 PET/CT: First-in-human Study
68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- First Affiliated Hospital of Fujian Medical University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.
Detailed description
Prostate cancer (PCa) is one of the most common malignancies worldwide in men. Prostate specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. Various low molecular weight radiopharmaceuticals targeting PSMA such as PSMA-11, PSMA-617 for 68Ga- or 177Lu- labeling have been developed. 68Ga-AAZTA-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the AAZTA chelator for labeling with 68Ga(III). This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT and compared with 68Ga-PSMA-11 and 68Ga-PSMA-617 PET/CT in the same group of prostate cancer patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga-AAZTA-093 | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-AAZTA-093. Tracer doses of 68Ga-AAZTA-093 will be used to image lesions of prostate cancer by PET/CT. |
| DRUG | 68Ga-PSMA-11//68Ga-PSMA-617 | Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-PSMA-11//68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-11/68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2024-07-01
- Completion
- 2024-10-01
- First posted
- 2024-05-31
- Last updated
- 2024-05-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06437496. Inclusion in this directory is not an endorsement.