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

NCT06763354 | Recruiting

• 1 other identifier: IIT-2024-0231
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Safety of Gallium[68Ga]NOTA-DNA Multivalent SGC8

  2 Year

• Accuracy in clinical parameters of Gallium[68Ga] NOTA-DNA multivalent SGC8

  2 Year

• Foci-distinguishing ability of Gallium [68Ga]NOTA-DNA multivalent SGC8

  2 Year

• The expression of PTK7 in bladder tumor tissues

  2 Year

Study Arms (1)

Patients with bladder tumors

EXPERIMENTAL

Radiation: Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection

Interventions

Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection RADIATION

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.

Patients with bladder tumors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 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

Peifeng Liu

CONTACT

86 13512116782; 2775@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Combination Product

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 8, 2025
• Study Start: February 8, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-01

Locations

CN (1)