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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Voluntary enrolment with signed informed consent

• Age \>18 years, \<85 years

• Cystoscopic diagnosis of bladder tumour with imaging and pathology reports not required

• Willingness and ability to follow trial protocol requirements.

Locations
Other Locations
China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Peifeng Liu
2775@renji.com
86 13512116782
Time Frame
Start Date: 2025-02-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Patients with bladder tumors
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov