Bladder Cancer Clinical Trial
Official title:
Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
Verified date | August 2023 |
Source | RenJi Hospital |
Contact | Haige Chen |
Phone | 13801796126 |
kirbyhaige[@]aliyun.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Renji Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
RenJi Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor specific lighting ability of [68Ga]-NOTA-SGC8 | Number of patients whose tumors are lightened under PET/MR with [68Ga]-NOTA-SGC8 | 2 year | |
Primary | Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8 | Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation | 2 year | |
Secondary | Staging ability of [68Ga]-NOTA-SGC8 | Accurate staging ability of [68Ga]-NOTA-SGC8 for bladder tumors | 2 year | |
Secondary | The expression of PTK7 in bladder tumor tissues | The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues | 2 year |
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