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Trial Title:
[68Ga] NOTA-SGC8 in the Staging of Bladder Cancer
NCT ID:
NCT06005116
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Bladder Cancer
[68Ga]-NOTA-SGC8
PET/MR
Bladder Irrigation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
[68Ga]-NOTA-SGC8
Description:
Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per
person per time according to body weight, no more than 5mCi. The participants will be
instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into
the bladder via catheter for 30 minutes to make full contact between the injection and
tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be
injected into the bladder to maintain the shape of the bladder.
Arm group label:
Bladder Cancer Patients
Summary:
The goal of this clinical trial is to test the imaging and diagnostic ability of
[68Ga]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main
questions it aims to answer are:
- Tumor specific lighting ability of [68Ga]-NOTA-SGC8 in bladder cancer patients with
different stages.
- The safety of [68Ga]-NOTA-SGC8. Participants will be irrigated with [68Ga]-NOTA-SGC8
into the bladder for tumor imaging under PET/MR. The imaging performance of
[68Ga]-NOTA-SGC8 on different stages of bladder tumors will be systematically
evaluated by combining with pathological sections of patients. Urine accumulation
and radioactivity distribution of [68Ga]-NOTA-SGC8 will be measured. The adverse
events will be recorded.
Detailed description:
Participants will be irrigated with [68Ga]-NOTA-SGC8 intravesically, with 0.05mCi/kg per
person per time according to body weight, no more than 5mCi. The participants will be
instructed to urinate cleanly before irrigation, and then irrigated [68Ga]-NOTA-SGC8 into
the bladder via catheter for 30 minutes to make full contact between the injection and
tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be
injected into the bladder to maintain the shape of the bladder.
To evaluate the efficacy of [68Ga]-NOTA-SGC8 in imaging bladder tumors, the following
indexes will be measured: specific imaging of the tumor area; specific imaging of its
target PTK7 receptor protein; distribution in major organs; PET/MR imaging after
administration; the absorbed dose of internal radiation based on the reference human
hormone model using OLINDA software.
Tumor tissues of patients will be collected, and pathological sections of relevant
patients will be analyzed after surgery. Immunohistochemistry will be used to verify the
expression of PTK7 receptor in corresponding tumors. The association between PTK7
receptor protein and tumor malignancy, invasion, and stage will be evaluated by molecular
imaging results.
All adverse events will be recorded within 24 hours after the administration of
[68Ga]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24
hours to 5 days after intravesical infusion. Blood and urine samples will be collected
and the concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with newly diagnosed or previously diagnosed bladder tumors.
- At least one cystoscopy was performed within one month prior to enrollment, and the
clinical diagnosis of bladder tumor was present.
- Age > 18 years, < 80 years
- Patients voluntarily participate and sign informed consent and are willing and able
to follow protocol requirements.
Exclusion Criteria:
- Pregnancy, lactation, severe liver and kidney insufficiency and children;
- Participants who are allergic to the experimental drug, have an allergic
disposition, or are allergic to multiple drugs.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Haige Chen
Phone:
13801796126
Email:
kirbyhaige@aliyun.com
Investigator:
Last name:
Haige Chen
Email:
Principal Investigator
Start date:
September 15, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06005116
