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

NCT ID: NCT05983796

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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18F-HER2 PET

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-HER2 PET

Group Type EXPERIMENTAL

18F-HER2 PET

Intervention Type DIAGNOSTIC_TEST

18F-HER2 PET

Interventions

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18F-HER2 PET

18F-HER2 PET

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianzhen Shan

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

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The First Affiliated Hospital, Zhejiang University School of medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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IIT20230066C

Identifier Type: -

Identifier Source: org_study_id

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