Clinical trial NCT06005116: [68Ga] NOTA-SGC8 in the Staging of Bladder Cancer
Official title: Exploratory Study on the Effectiveness of Gallium [68Ga] NOTA-SGC8 Injection in the Staging of Bladder Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder Cancer
[68Ga]-NOTA-SGC8
PET/MR
Bladder Irrigation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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 After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.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.

Eligibility 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.

Primary outcomes:
measure: Tumor specific lighting ability of [68Ga]-NOTA-SGC8
timeFrame: 2 year
measure: Incidence of treatment-related adverse events of [68Ga]-NOTA-SGC8
timeFrame: 2 year
Secondary outcomes:
measure: Staging ability of [68Ga]-NOTA-SGC8
timeFrame: 2 year
measure: The expression of PTK7 in bladder tumor tissues
timeFrame: 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: