Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases

March 9, 2026 updated by: Zhaohui Zhu, Peking Union Medical College Hospital
The purpose of this study is to conduct clinical research on [68Ga] Ga-NI-FAPI-04 PET/CT imaging and further investigate its diagnostic value in fibroblast activation related diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
        • Contact:

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

Yes

Description

Inclusion Criteria:

  • 1: 18-85 years old

    2: Tumor patients can undergo surgery or biopsy to obtain pathological diagnosis

    3: Ability to understand and sign informed consent forms

    4: Expected survival period exceeding 6 months and able to receive follow-up

    5: Healthy volunteers without chronic medical history of hypertension, diabetes, coronary heart disease, kidney disease, tumor, etc

Exclusion Criteria:

  • 1: Pregnant or lactating women

    2: Patients allergic to research drug ingredients

    3: Patients with severe liver and kidney dysfunction (blood creatinine levels exceeding 159 μ mol/L)

    4: Patients who participate in other clinical trials and interfere with the results of this study

    5: Patients with severe illness who cannot cooperate with the examination

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: NI-FAPI group
Injection of [68Ga]Ga-NI-FAPI
Drug: Injection of 68Ga-NI-FAPI
Subjects were injected with 68Ga-NI-FAPI at 0.4-0.5mci/kg body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of PET/CT Images of [68Ga] Ga-NI-FAPI-04
Time Frame: Within 30-120 minutes after intravenous injection of imaging agent
Semi quantitative analysis (measuring lesion standard uptake value (SUV), then calculating lesion SUV to liver/blood pool SUV ratio)
Within 30-120 minutes after intravenous injection of imaging agent

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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 (Actual)

December 17, 2025

Primary Completion (Estimated)

February 17, 2027

Study Completion (Estimated)

June 17, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-25PJ0568

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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