Using [68Ga] NOTA-SGC8 for imaging bladder cancer
Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
This study is testing a new imaging agent to see if it can help doctors better see and understand bladder cancer in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06005116 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the imaging and diagnostic capabilities of [68Ga]-NOTA-SGC8 PET/MR in patients with bladder cancer at various stages. Participants will receive an intravesical irrigation of [68Ga]-NOTA-SGC8 to enhance tumor visibility during imaging. The study will assess the safety of the agent, its distribution in the body, and its effectiveness in identifying tumor characteristics through pathological analysis. Adverse events will be monitored closely to ensure participant safety.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with newly diagnosed or previously diagnosed bladder tumors who have undergone a recent cystoscopy.
Not a fit: Patients who are pregnant, lactating, or have severe liver and kidney insufficiencies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the accuracy of bladder cancer staging and treatment planning.
How similar studies have performed: While the use of PET/MR imaging in cancer diagnostics is established, the specific application of [68Ga]-NOTA-SGC8 for bladder cancer is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- Renji Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Haige Chen
- Email: kirbyhaige@aliyun.com
- Phone: 13801796126
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.