Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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 After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder Cancer Patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]-NOTA-SGC8 | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor specific lighting ability of [68Ga]-NOTA-SGC8 | Number of patients whose tumors are lightened under PET/MR with [68Ga]-NOTA-SGC8 | 2 year |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Staging ability of [68Ga]-NOTA-SGC8 | Accurate staging ability of [68Ga]-NOTA-SGC8 for bladder tumors | 2 year |
| The expression of PTK7 in bladder tumor tissues | The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haige Chen | Contact | 13801796126 | kirbyhaige@aliyun.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2024 | |
| Reset | Jan 6, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2024 | Jan 6, 2025 |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2 year |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |