68Ga-FAPI PET/CT in Malignant Tumors

May 31, 2025 updated by: Yong He, Zhongnan Hospital

The Diagnostic Efficiency of 68Ga-FAPI PET/CT in Malignant Tumors

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The morbidity and mortality of malignant tumors are increasing. It is one of the major diseases that affect human health. At present, the conventional imaging diagnosis methods of a variety of malignant tumors are mainly CT and MRI based on anatomical imaging. Different from traditional imaging methods to visually display the lesion, nuclear medicine molecular imaging can not only locate the tumor location, but also image the expression and activity of specific molecules and biological processes. This molecular imaging method integrating anatomy and function is a noninvasive imaging to realize the early diagnosis and differential diagnosis, curative effect evaluation and follow-up observation of a variety of tumors. Positron emission tomography/computed tomography (PET/CT) uses specific molecular probes to target tumor. It can provide detailed information about the biochemical changes of tumor tissues at the cellular and molecular levels. It has better sensitivity and specificity than conventional imaging methods. At present, the most commonly used imaging agent in clinic is 18F-fluorodeoxyglucose (18F-FDG). 18F-FDG PET/CT is a valuable imaging modality in the management of patients with malignant tumors, but it is not a specific imaging agent for tumor application. The physiological uptake of gastrointestinal tract, infected tissues, or inflammatory cells can cause high 18F-FDG uptake resulting in a significant increase of the false positive rate; in addition, some tumors including well-differentiated hepatocellular carcinoma, renal cell carcinoma, and gastric signet ring cell carcinoma have low 18F-FDG uptake resulting in a high false negative rate. Therefore, it is very important to develop new molecular probes for targeting tumor.

Fibroblast-activation protein (FAP) is a type Ⅱ transmembrane serine protease and is overexpressed in cancer-associated fibroblasts (CAFs). CAFs are the predominant component in the stroma of epithelial neoplasms. FAP can be detected in various of malignant neoplasms and is associated to tumor cell migration, invasion, and angiogenesis. Recently, a novel molecular probe, gallium 68-labelled FAP inhibitor (68Ga-FAPI), has been developed and used for visualization of tumor stroma by targeting FAP. Recent studies show favorable diagnosis efficiency in a variety of tumors, especially in gastrointestinal cancer, but the previous studies were all small-sample data or case reports. Therefore, further large-size research is necessary to confirm the advantages of 68Ga-FAPI in various of malignant tumors.

Study Type

Interventional

Enrollment (Estimated)

500

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 Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital Of Wuhan University
        • Contact:
          • Lei Zheng
          • Phone Number: +86-27-67812787
        • Principal Investigator:
          • Yong He, MD, PhD

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Volunteering to participate in clinical trial and sign an informed consent form Patients with suspected or confirmed malignant tumor

Exclusion Criteria:

Female patients plan to become pregnant within 6 months Pregnant and lactating women Patients are allergic to multiple drugs including test drug Patients have participated in other clinical trials in the past one month

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: 68Ga-FAPI PET/CT in malignant tumors
Investigators select subjects from patients who have underwent whole-body 18F-FDG PET/CT scan for suspected or confirmed malignancy, or suspected recurrence and metastasis after treatment for malignant tumors, focusing on malignant tumors with low FDG uptake including glioma, hepatocellular carcinoma, renal cancer, gastrointestinal cancer, and peritoneal metastases. Then the subjects receive whole-body 68Ga-FAPI PET/CT scan with time interval of one to four week.
Drug: 68Ga-FAPI
68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).
Other Names:
  • 68Ga-fibroblast activation protein inhibitor
Device: PET/CT
68Ga-FAPI PET/CT scan were performed 20~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.
Other Names:
  • positron emission tomography/computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic sensitivity and specificity of 68Ga-FAPI PET/CT in the staging of malignant tumors
Time Frame: three years
Taking the pathology or clinical follow-up as gold standard, the sensitivity and specificity of 68Ga-FAPI PET/CT in detecting malignant tumor were calculated.
three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of FAPI PET parameters in malignant tumors
Time Frame: From baseline to 1 year post-treatment
Correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and long-term outcomes (e.g., progression-free survival, overall survival).
From baseline to 1 year post-treatment
FAPI PET for therapeutic response evaluation in malignant tumors
Time Frame: Within 1 week after completion of neoadjuvant or adjuvant therapy
Assessment of FAPI PET parameters, namely SUVmax, SUVmean, SUVpeak, measured in the Syngo Workstation (Siemens Healthineers), for evaluating treatment response in patients with malignant tumors.
Within 1 week after completion of neoadjuvant or adjuvant therapy
The connection between FAPI PET parameters and histopathological biomarkers.
Time Frame: Within 4 weeks of FAPI PET scan
Analyze the correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and FAP expression levels (H-score; immunohistochemistry) or immune - related biomarkers, such as PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay), CD8 expression (H-score; immunohistochemistry), Granzyme B expression (H-score; immunohistochemistry).
Within 4 weeks of FAPI PET scan

Collaborators and Investigators

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

Sponsor

Zhongnan Hospital

Investigators

  • Principal Investigator: Yong He, MD, PhD, Zhongnan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 23, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 25, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

May 31, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZNYYHYXK0001

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

product manufactured in and exported from the U.S.

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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