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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400088958
Enrollment
Unknown
Registered
2024-08-29
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urothelial carcinoma

Interventions

Group 1 18F/68Ga-SMIC-4200 PET:18F/68Ga-SMIC-4200 iv

Sponsors

Shanghai 10th People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
total volume of HER/FDG2 positive tumor;The SUVmax of HER/FDG2 positive tumor ;

Secondary

MeasureTime frame
The change of SUVmax of HER/FDG positive tumor before and after treatment;

Countries

China

Contacts

Public ContactMA CHAO

Shanghai 10th People's Hospital

ponymachao@163.com+86 187 2128 8964

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026