The Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
NCT ID: NCT06763354
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-02-08
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with bladder tumors
Gallium[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.
Interventions
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Gallium[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.
Eligibility Criteria
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Inclusion Criteria
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
2. Hypersensitivity to the test drug, allergy or allergy to multiple drugs
18 Years
85 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Liu Peifeng
Principal Investigator
Locations
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Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2024-0231
Identifier Type: -
Identifier Source: org_study_id
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