To hear about similar clinical trials, please enter your email below
Trial Title:
68Ga-AAZTA-NI-093 PET/CT: First-in-human Study
NCT ID:
NCT06612580
Condition:
Prostate Cancer (Adenocarcinoma)
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
PSMA
Prostate cancer
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-AAZTA-NI-093
Description:
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.
Arm group label:
68Ga-AAZTA-NI-093 PET/ CT
Summary:
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.
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-NI-093 is a novel agent
incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a PSMA-targeting. This
pilot study was prospectively designed to evaluate the safety, biodistribution, radiation
dosimetry and diagnostic value of 68Ga-AAZTA-NI-093 PET/CT in prostate cancer patients.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
+86-0591-87981618
Email:
miaoweibing@126.com
Contact backup:
Last name:
Guochang Wang, MD
Phone:
+86-0591-87981619
Email:
guochang1007@163.com
Start date:
September 1, 2024
Completion date:
December 31, 2025
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/NCT06612580
