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Trial Title:
18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
NCT ID:
NCT05983796
Condition:
18F-HER2 PET
Conditions: Official terms:
Carcinoma, Transitional Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F-HER2 PET
Description:
18F-HER2 PET
Arm group label:
18F-HER2 PET
Summary:
This is a open-label, one-arm, multicenter study aimed to explore the efficacy and safety
of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Informed consent document must be signed.
2. Aged 30-80 years old, both genders.
3. Patients with locally advanced or advanced urothelial carcinoma
4. Patients plan to undergo anti HER2 treatment.
Exclusion Criteria:
1. Subjects with active malignancies other than urothelial carcinoma within 5 years
should be excluded.
2. Patients with severe liver, kidney, and hematopoietic diseases
3. Patients with other mental disorders or primary emotional disorders
4. Those who are unable to understand, comply with the research protocol, or sign an
informed consent form
5. PET imaging Contraindication (including pregnant women, lactating women, women of
childbearing age who have a recent fertility plan, etc.)
6. Individuals who are allergic to imaging agents
7. Hypoglycemic reactions, severe pain, etc. cannot be accompanied by PET scans
Gender:
All
Minimum age:
30 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Start date:
August 10, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Source:
First Affiliated Hospital of Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983796
