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[68Ga] NOTA-SGC8 in the Staging of Bladder Cancer

NCT06005116 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-08-22

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

[68Ga]-NOTA-SGC8

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 After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005116 on ClinicalTrials.gov