Using 68Ga-PSMA-33 for imaging prostate cancer
Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
This study is testing a new imaging agent called 68Ga-PSMA-33 to see if it can safely and effectively help find prostate cancer earlier than current methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06054789 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of 68Ga-PSMA-33 for the early diagnosis of prostate cancer. It aims to determine the pharmacokinetics, dosimetry, tolerance, and tumor detection rate of this new PSMA-targeted probe. Eight volunteers with prostate cancer will receive an intravenous injection of 68Ga-PSMA-33 and undergo PET/CT imaging at various time intervals. The results will be compared with those from patients receiving another imaging agent, 68Ga-PSMA-617.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with confirmed localized or metastatic prostate cancer.
Not a fit: Patients under 18 years old or those who have received prior radioisotope diagnosis or treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the early detection and diagnosis of prostate cancer, leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promise with PSMA-targeted imaging agents, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- 68Ga-PSMA-33 PET/CT imaging — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Feng Wang
- Email: fengwangcn@hotmail.com
- Phone: 02552271276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.