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

Not Applicable

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT06763354
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-22
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Study Start: 2025-02-08
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China