68Ga-NI-FAPI PET/CT: First-in-human Study

NCT ID: NCT06688305

Last Updated: 2024-11-14

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-31

Brief Summary

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68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.

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, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.

Conditions

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Malignant Neoplasm

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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68Ga-NI-FAPI PET/CT

PET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI.

Group Type EXPERIMENTAL

68Ga-NI-FAPI

Intervention Type DRUG

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.

Interventions

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68Ga-NI-FAPI

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.

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

First Affiliated Hospital of Fujian Medical University

Locations

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Department of Nuclear Medicine, 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

Jie Zang, MD

Role: CONTACT

+86-0591-87981619

Facility Contacts

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Jie Zang, PhD, MD

Role: primary

86-0591-87981619

Weibing Miao, MD

Role: backup

MD 86-0591-87981618

Other Identifiers

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FirstAHFujian-68Ga-NI-FAPI

Identifier Type: -

Identifier Source: org_study_id

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