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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Bladder Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06763354

IIT-2024-0231

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patients with bladder tumors

Experimental group

Treatment:

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