Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-PSMA-33 For the injection, subjects will receive a target dose of 3-7mCi 68Ga-PSMA-33 as a bolus injection. Among them, 3~4 subjects will additionally inject with 68Ga-PSMA-617 (3-7mCi). |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Tumor detection rate [2 years]
Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
- Standardized uptake value (SUV) of tumor [2 years]
Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Secondary Outcome Measures
- Safety and Tolerability Profile Measured by Adverse Events (AEs) [2 years]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male sex
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Age 18 years or older
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Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer
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Creatinine less than or equal to 1.5 X upper limit of normal
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ECOG performance status 0 - 2, inclusive
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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.
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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.
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Able to understand and provide written informed consent
Exclusion Criteria:
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Patient age < 18 years
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Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives
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Malignancy other than current disease under study
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Patient simultaneously participating in another clinical trial
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Patient who cannot stay on PET/CT
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Patient with HIV, HCV, HVB infection or other serious chronic infection
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Patient with liver and kidney function (GFR less than 50 ml/min) disease
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Cannot receive furosemide, allergy to sulfa or sulfa-containing medications
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 68Ga-PSMA-33 PET/CT imaging | Nanjing | Jiangsu | China | 210006 |
Sponsors and Collaborators
- Nanjing First Hospital, Nanjing Medical University
Investigators
- Study Director: Feng Wang, Nanjing First Hospital, Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 68Ga-PSMA-33