Clinical trial · Interventional
[68Ga] NOTA-SGC8 in the Staging of Bladder Cancer
Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
- 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 goal of this clinical trial is to test the imaging and diagnostic ability of \[68Ga\]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions it aims to answer are: * Tumor specific lighting ability of \[68Ga\]-NOTA-SGC8 in bladder cancer patients with different stages. * The safety of \[68Ga\]-NOTA-SGC8. Participants will be irrigated with \[68Ga\]-NOTA-SGC8 into the bladder for tumor imaging under PET/MR. The imaging performance of \[68Ga\]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated by combining with pathological sections of patients. Urine accumulation and radioactivity distribution of \[68Ga\]-NOTA-SGC8 will be measured. The adverse events will be recorded.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]-NOTA-SGC8 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bladder Cancer Patients
- interventionNames
- Radiation: [68Ga]-NOTA-SGC8
Primary outcomes (2)
- measure
- Tumor specific lighting ability of [68Ga]-NOTA-SGC8
- timeFrame
- 2 year
- description
- Number of patients whose tumors are lightened under PET/MR with \[68Ga\]-NOTA-SGC8
- measure
- Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8
- timeFrame
- 2 year
- description
- Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed or previously diagnosed bladder tumors. * At least one cystoscopy was performed within one month prior to enrollment, and the clinical diagnosis of bladder tumor was present. * Age \> 18 years, \< 80 years * Patients voluntarily participate and sign informed consent and are willing and able to follow protocol requirements. Exclusion Criteria: * Pregnancy, lactation, severe liver and kidney insufficiency and children; * Participants who are allergic to the experimental drug, have an allergic disposition, or are allergic to multiple drugs.
References
Publications (0)
Data not yet available