Clinical trial · Interventional
Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
NCT06054789CI-TRIAL-00069944unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-33 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA-33
- description
- 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).
- interventionNames
- Drug: 68Ga-PSMA-33
Primary outcomes (2)
- measure
- Tumor detection rate
- timeFrame
- 2 years
- description
- Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
- measure
- Standardized uptake value (SUV) of tumor
- timeFrame
- 2 years
- description
- Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.