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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06054789
Other study ID # 68Ga-PSMA-33
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2024

Study information

Verified date September 2023
Source Nanjing First Hospital, Nanjing Medical University
Contact Feng Wang
Phone 02552271276
Email fengwangcn@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa).


Description:

This study is design to prospectively investigate the safety and efficacy of 68Ga-PSMA-33 in the early diagnosis of Prostate Cancer (PCa). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-PSMA-33 in patient with PCa. While PSMA is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make PSMA an attractive target for the diagnosis and treatment of PCa. 68Ga-PSMA-33 as a new PSMA targeted probe was prepared and showed good uptake on PCa cell line and animal studies. The study intends to recruit 8 PCa volunteers to participate in the experiment. All patients were intravenously injected with 68Ga-PSMA-33 and underwent PET/CT at 0.5, 1, 2 and 4 h, respectively. For comparison, 3 patients were additionally received 68Ga-PSMA-617 PET/CT imaging. The images were interpreted by two experienced physician and the SUVmax or SUVmean of physiological organs and tumor lesions were collected.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date October 1, 2024
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Male sex - Age 18 years or older - Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer - Creatinine less than or equal to 1.5 X upper limit of normal - ECOG performance status 0 - 2, inclusive - Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation Patient with complete clinical data. - The effects of 68Ga-PSMA-33 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. - Able to understand and provide written informed consent Exclusion Criteria: - Patient age < 18 years - Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives - Malignancy other than current disease under study - Patient simultaneously participating in another clinical trial - Patient who cannot stay on PET/CT - Patient with HIV, HCV, HVB infection or other serious chronic infection - Patient with liver and kidney function (GFR less than 50 ml/min) disease - Cannot receive furosemide, allergy to sulfa or sulfa-containing medications - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
68Ga-PSMA-33
Subjects will receive one injection of 68Ga-PSMA-33/PSMA-617 (3-7mCi ), a PET radiopharmaceutical selective for Prostate-Specific Membrane Antigen. 68Ga-PSMA-33/PSMA-617 injection will be followed by a 10 ml saline flush.

Locations

Country Name City State
China 68Ga-PSMA-33 PET/CT imaging Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor detection rate Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT. 2 years
Primary Standardized uptake value (SUV) of tumor Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT. 2 years
Secondary Safety and Tolerability Profile Measured by Adverse Events (AEs) Safety and tolerability profile for the administration of 68Ga-PSMA-33 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs). 2 years
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