[68Ga] NOTA-SGC8 in the Staging of Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005116
• Other study ID #: IIT-2022-0239
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: Haige Chen
• Phone: 13801796126
• Email: kirbyhaige[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder. To evaluate the efficacy of [68Ga]-NOTA-SGC8 in imaging bladder tumors, the following indexes will be measured: specific imaging of the tumor area; specific imaging of its target PTK7 receptor protein; distribution in major organs; PET/MR imaging after administration; the absorbed dose of internal radiation based on the reference human hormone model using OLINDA software. Tumor tissues of patients will be collected, and pathological sections of relevant patients will be analyzed after surgery. Immunohistochemistry will be used to verify the expression of PTK7 receptor in corresponding tumors. The association between PTK7 receptor protein and tumor malignancy, invasion, and stage will be evaluated by molecular imaging results. All adverse events will be recorded within 24 hours after the administration of [68Ga]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24 hours to 5 days after intravesical infusion. Blood and urine samples will be collected and the concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Radiation:
• [68Ga]-NOTA-SGC8
Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

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