Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437496
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
68Ga-AAZTA-093 PETCT First-in-human Study
Sponsor:
First Affiliated Hospital of Fujian Medical University
Organization:
First Affiliated Hospital of Fujian Medical University
Study Overview
Official Title:
68Ga-AAZTA-093 PETCT First-in-human Study in Patients With Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PETCT 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 68GaIII This pilot study was prospectively designed to evaluate the safety biodistribution radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PETCT and compared with 68Ga-PSMA-11 and 68Ga-PSMA-617 PETCT in the same group of prostate cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None