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

NCT06005116 | Unknown

• 1 other identifier: IIT-2022-0239
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Bladder Cancer; [68Ga]-NOTA-SGC8; PET/MR; Bladder Irrigation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Staging ability of [68Ga]-NOTA-SGC8

  2 year

• The expression of PTK7 in bladder tumor tissues

  2 year

Study Arms (1)

Bladder Cancer Patients

EXPERIMENTAL

Radiation: [68Ga]-NOTA-SGC8

Interventions

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 After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.

Bladder Cancer Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Haige Chen

CONTACT

13801796126; kirbyhaige@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: August 22, 2023
• Study Start: September 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)