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

August 14, 2023 updated by: RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.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

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • RenJi Hospital
        • Contact:
        • Principal Investigator:
          • Haige Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bladder Cancer Patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor specific lighting ability of [68Ga]-NOTA-SGC8
Time Frame: 2 year
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
Time Frame: 2 year
Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staging ability of [68Ga]-NOTA-SGC8
Time Frame: 2 year
Accurate staging ability of [68Ga]-NOTA-SGC8 for bladder tumors
2 year
The expression of PTK7 in bladder tumor tissues
Time Frame: 2 year
The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 29, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2022-0239

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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