Gallium injection for imaging bladder tumors
An Exploratory Clinical Study of the Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
This study is testing a new injection to see if it can help better image bladder tumors in patients who have already been diagnosed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06763354 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Gallium[68Ga]NOTA-DNA multivalent SGC8 injection for imaging bladder tumors in patients attending the Department of Urology at Renji Hospital. Patients aged 18 to 85 with a cystoscopic diagnosis of bladder tumors will receive the injection followed by PET/MR imaging to assess tumor-specific imaging capabilities. The study aims to compare the imaging results with the gold standard TUR pathology to determine the efficacy and safety of the injection. Patient demographics and medical histories will be monitored throughout the study period from September 2024 to December 2025.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a cystoscopic diagnosis of bladder tumors.
Not a fit: Patients who are pregnant, breastfeeding, or have severe hepatic or renal insufficiency will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of bladder tumor imaging, leading to better diagnosis and treatment planning for patients.
How similar studies have performed: While this specific approach is novel, similar imaging techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai
- Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Peifeng Liu
- Email: 2775@renji.com
- Phone: 86 13512116782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.