Back to results18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
Primary Purpose
18F-HER2 PET
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-HER2 PET
Sponsored by
About this trial
This is an interventional diagnostic trial for 18F-HER2 PET
Eligibility Criteria
Inclusion Criteria: Informed consent document must be signed. Aged 30-80 years old, both genders. Patients with locally advanced or advanced urothelial carcinoma Patients plan to undergo anti HER2 treatment. Exclusion Criteria: Subjects with active malignancies other than urothelial carcinoma within 5 years should be excluded. Patients with severe liver, kidney, and hematopoietic diseases Patients with other mental disorders or primary emotional disorders Those who are unable to understand, comply with the research protocol, or sign an informed consent form PET imaging Contraindication (including pregnant women, lactating women, women of childbearing age who have a recent fertility plan, etc.) Individuals who are allergic to imaging agents Hypoglycemic reactions, severe pain, etc. cannot be accompanied by PET scans
Sites / Locations
- The First Affiliated Hospital, Zhejiang University School of medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-HER2 PET
Arm Description
Outcomes
Primary Outcome Measures
Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma
Secondary Outcome Measures
Full Information
NCT ID
NCT05983796
First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05983796
Brief Title
18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
Official Title
Prospective Study of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
18F-HER2 PET
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-HER2 PET
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-HER2 PET
Intervention Description
18F-HER2 PET
Primary Outcome Measure Information:
Title
Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent document must be signed.
Aged 30-80 years old, both genders.
Patients with locally advanced or advanced urothelial carcinoma
Patients plan to undergo anti HER2 treatment.
Exclusion Criteria:
Subjects with active malignancies other than urothelial carcinoma within 5 years should be excluded.
Patients with severe liver, kidney, and hematopoietic diseases
Patients with other mental disorders or primary emotional disorders
Those who are unable to understand, comply with the research protocol, or sign an informed consent form
PET imaging Contraindication (including pregnant women, lactating women, women of childbearing age who have a recent fertility plan, etc.)
Individuals who are allergic to imaging agents
Hypoglycemic reactions, severe pain, etc. cannot be accompanied by PET scans
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianzhen Shan
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.
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