Bladder Cancer
Conditions
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.
Interventions
RADIATIONGallium[68Ga]NOTA-DNA Multivalent SGC8 Injection
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.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Combination Product
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor specific lighting ability of Gallium[68Ga]NOTA-DNA Multivalent SGC8 | 2 year | Number of patients whose tumors are lightened under PET/MR with Gallium\[68Ga\]NOTA-DNA Multivalent SGC8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Gallium[68Ga]NOTA-DNA Multivalent SGC8 | 2 Year | Adverse events within 24 hours of intravesical irrigation; Serious adverse events within 5 days of intravesical irrigation |
| Accuracy in clinical parameters of Gallium[68Ga] NOTA-DNA multivalent SGC8 | 2 Year | Correlation between gallium\[68Ga\] NOTA-DNA multivalent SGC8 images and clinical parameters |
| Foci-distinguishing ability of Gallium [68Ga]NOTA-DNA multivalent SGC8 | 2 Year | The ability of gallium \[68Ga\]NOTA-DNA multivalent SGC8 to differentiate between bladder tumor foci and inflammatory foci |
| The expression of PTK7 in bladder tumor tissues | 2 Year | The expression of \[68Ga\]-NOTA-SGC8 target PTK7 receptor protein in bladder tumor tissues |
Countries
China
Contacts
Primary ContactPeifeng Liu
Outcome results
None listed