The Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging

An Exploratory Clinical Study of the Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging

The study was planned to include patients with bladder tumors attending the Department of Urology, Renji Hospital, Shanghai Jiaotong University School of Medicine, from 09/2024 to 12/2025. Patient demographics will be collected, patients will be monitored for medical history and co-morbidities, co-morbid medications or treatments, vital signs, and cystoscopy will be performed. Patients meeting the inclusion criteria will be included in this study. Patients will receive PET/MR imaging after bladder instillation of [68Ga] NOTA-DNA multivalent SGC8 injection to assess the effectiveness of bladder tumor imaging and to evaluate the safety of [68Ga] NOTA-DNA multivalent SGC8.

The primary study was the ability of gallium [68Ga] NOTA-DNA multivalent SGC8 injection to provide tumor-specific imaging of bladder tumor patients of different genders, with a compliance rate of more than 80% when compared to the gold standard TUR pathology. To study the safety of gallium[68Ga] NOTA-DNA multivalent SGC8 injection; to assess the correlation between gallium[68Ga] NOTA-DNA multivalent SGC8 imaging ability and clinical parameters; to study the ability of gallium [68Ga]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci; to explore the gallium [68Ga]NOTA- DNA multivalent SGC8 target PTK7 receptor protein expression in bladder tumors and the correlation between tumor differentiation and malignancy.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Radiation: Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peifeng Liu; Phone Number: 86 13512116782; Email: 2775@renji.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Renji Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Di Jin; Phone Number: 13501840824; Email: rjbladder@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntary enrolment with signed informed consent
2. Age >18 years, <85 years
3. Cystoscopic diagnosis of bladder tumour with imaging and pathology reports not required
4. Willingness and ability to follow trial protocol requirements.

Exclusion Criteria:

1. Pregnancy, breastfeeding, severe hepatic, renal insufficiency and children
2. Hypersensitivity to the test drug, allergy or allergy to multiple drugs

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with bladder tumors

Radiation: Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection; On the examination bed, the patient was placed in the lying truncated position, the perineum was disinfected with a towel, and a double-lumen urinary catheter was inserted via the perineum.Inject 50ml saline to clean the bladder once, open the drainage bag to drain.1mci SGC8 was dissolved in 50ml physiological saline. The drainage bag was clamped shut and 50ml of developer was injected into the bladder through the catheter, followed by 10ml of gas or saline (all developer in the ureter was injected into the bladder. The catheter was closed for 1 hour, during which time the patient was placed in the flat position, left lateral position, right lateral position, and supine position changing positions every 15 minutes.After 1 hour, the drainage bag was opened, the bladder was emptied with radioactive fluid, and the urine bag was replaced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor specific lighting ability of Gallium[68Ga]NOTA-DNA Multivalent SGC8	Number of patients whose tumors are lightened under PET/MR with Gallium[68Ga]NOTA-DNA Multivalent SGC8	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Gallium[68Ga]NOTA-DNA Multivalent SGC8	Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation	2 Year
Accuracy in clinical parameters of Gallium[68Ga] NOTA-DNA multivalent SGC8	Correlation between gallium[68Ga] NOTA-DNA multivalent SGC8 images and clinical parameters	2 Year
Foci-distinguishing ability of Gallium [68Ga]NOTA-DNA multivalent SGC8	The ability of gallium [68Ga]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci	2 Year
The expression of PTK7 in bladder tumor tissues	The expression of [68Ga]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues	2 Year

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 22, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: IIT-2024-0231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No