18F/68Ga-SMIC-4200 PET/CT quantification of HER2 expression in locally advanced or metastatic urothelial carcinoma to guide HER2-targeted drug therapy

Phase 1

• Conditions: urothelial carcinoma

• Registration Number: ChiCTR2400088958
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diagnostic criteria:<br>(1) urothelial carcinoma was pathologically diagnosed; (2) Locally advanced urothelial carcinoma or metastatic urothelial carcinoma.<br><br>1) Meet the above diagnostic criteria;<br>2) Age >18 years old;<br>3) HER2 targeted drug therapy is proposed;<br>4) Male and female sex is not limited.

Exclusion Criteria

(1) Under 18 years of age;<br>(2) The pathological diagnosis of HER2 in the primary lesion could not be obtained;<br>(3) Patients who do not want to participate in the study or do not want to sign informed consent;<br>(4) Critically ill patients, suffering from mental diseases, can not cooperate with the examination of patients;<br>(5) Pregnant and lactating women;<br>(6) Severe heart diseases such as heart obstruction, heart failure, and unstable angina within 3 months;<br>(7) Severely impaired liver function (AST or ALT> 4 times the upper limit of normal);<br>(8) Renal insufficiency (BUN or CR> 2 times the upper limit of normal);<br>(9) Embolic diseases such as venous thrombosis or pulmonary embolism;<br>(10) Infectious diseases such as urinary system infection, respiratory system infection;<br>(11) Have been or are receiving HER2-targeted drug therapy.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total volume of HER/FDG2 positive tumor;The SUVmax of HER/FDG2 positive tumor ;

Secondary Outcome Measures

Name	Time	Method
The change of SUVmax of HER/FDG positive tumor before and after treatment;