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Trial Title:
68Ga-AAZTA-093 PET/CT: First-in-human Study
NCT ID:
NCT06437496
Condition:
Malignant Neoplasm of Prostate
Conditions: Official terms:
Neoplasms
Prostatic Neoplasms
Gallium 68 PSMA-11
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-AAZTA-093
Description:
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.
Arm group label:
68Ga-AAZTA-093 PET/ CT
Intervention type:
Drug
Intervention name:
68Ga-PSMA-11//68Ga-PSMA-617
Description:
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.
Arm group label:
68Ga-PSMA-11/68Ga-PSMA-617 PET/ CT
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- confirmed treated or untreated prostate cancer patients;
- 68Ga-AAZTA-093 and 68Ga-PSMA-11/68Ga-PSMA-617 PET/CT within 1 week;
- 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Guochang Wang, MD
Phone:
86-0591-87981619
Email:
guochang1007@163.com
Start date:
April 1, 2024
Completion date:
October 1, 2024
Lead sponsor:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06437496
