68Ga-JH04 PET/CT in Patients With Various Types of Cancer

NCT ID: NCT06455735

Last Updated: 2024-06-12

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

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-04-01

Brief Summary

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As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-JH04 is promising as an excellent imaging agent for various cancers. In this study, we observed the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Detailed Description

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Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, showing high efficacy in tumor staging and restaging. As an emerging molecule targeting FAP, 68Ga-JH04, in this study, the diagnostic performance of 68Ga-JH04 PET/CT in patients with different types of cancer were observed. Its imaging results were compared with those of 68Ga-FAPI or 18F-FDG PET/CT.

Conditions

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Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-JH04 PET/ CT

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-JH04. Tracer doses of 68Ga-JH04 will be used to detect tumors by PET/CT.

Group Type EXPERIMENTAL

68Ga-JH04

Intervention Type DRUG

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-JH04. Tracer doses of 68Ga-JH04 will be used to detect tumors by PET/CT.

68Ga-FAPI/18F-FDG PET/ CT

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.

Group Type EXPERIMENTAL

68Ga-FAPI/18F-FDG

Intervention Type DRUG

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.

Interventions

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68Ga-JH04

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-JH04. Tracer doses of 68Ga-JH04 will be used to detect tumors by PET/CT.

Intervention Type DRUG

68Ga-FAPI/18F-FDG

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Various solid tumors with available histopathological findings Signed informed consent

Exclusion Criteria

pregnant or lactational women who suffered from severe hepatic and renal insufficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weibing Miao, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital, Fujian Medical University

Locations

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The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibing Miao, MD

Role: CONTACT

+86-0591-87981618

Guochang Wang, PhD

Role: CONTACT

+86-0591-87981619

Facility Contacts

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Weibing Miao, MD

Role: primary

+86-0591-87981618

Guochang Wang, PhD

Role: backup

+86-0591-87981619

Other Identifiers

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FirstAHFujian-68Ga-JH04 PET/CT

Identifier Type: -

Identifier Source: org_study_id

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