Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06763354

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

Led by RenJi Hospital · Updated on 2025-03-14

20

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary enrolment with signed informed consent
  • Age greater than 18 years and less than 85 years
  • Cystoscopic diagnosis of bladder tumor
  • Willingness and ability to follow trial protocol requirements
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Severe liver or kidney failure
  • Children (under 18 years)
  • Hypersensitivity to the study drug or allergies to multiple drugs

AI-Screening

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Trial Site Locations

Total: 1 location

1

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Actively Recruiting

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Research Team

P

Peifeng Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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