18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.

August 2, 2023 updated by: First Affiliated Hospital of Zhejiang University

Prospective Study of 18F-HER2 PET in Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The first Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-HER2 PET
Diagnostic test: 18F-HER2 PET
18F-HER2 PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluating the Efficacy of Anti-HER2 Therapy for Urothelial Carcinoma
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

  • Principal Investigator: Jianzhen Shan, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20230066C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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