Clinical trial NCT06763354: The Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
Official title: An Exploratory Clinical Study of the Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Combination Product
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Tumor specific lighting ability of Gallium[68Ga]NOTA-DNA Multivalent SGC8
timeFrame: 2 year
Secondary outcomes:
measure: Safety of Gallium[68Ga]NOTA-DNA Multivalent SGC8
timeFrame: 2 Year
measure: Accuracy in clinical parameters of Gallium[68Ga] NOTA-DNA multivalent SGC8
timeFrame: 2 Year
measure: Foci-distinguishing ability of Gallium [68Ga]NOTA-DNA multivalent SGC8
timeFrame: 2 Year
measure: The expression of PTK7 in bladder tumor tissues
timeFrame: 2 Year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References: