A Prospective Study on the Diagnosis of Malignant Tumors With 18F-FGIn PET/CT

May 16, 2026 updated by: Rusen Zhang, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Glutamine is a crucial nutrient for cancer cell growth, and its metabolism is frequently dysregulated in malignancies. 18F-FGln is a PET tracer that targets this altered glutamine metabolism. However, there are currently limited studies on the diagnostic value of 18F-FGln PET/CT in various types of cancer. Therefore, this prospective study was conducted to investigate the value of 18F-FGln PET/CT in patients with various types of malignant tumors.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Glutamine is the most abundant amino acid in plasma and a key metabolic fuel for cancer cells. The process of glutaminolysis supports tumor growth by providing carbon, nitrogen, and energy. PET imaging of glutamine flux using the radiotracer 18F-(2S,4R)-4-fluoroglutamine (18F-FGln) offers a novel approach to visualize a hallmark of cancer metabolism in vivo. Early human trials have demonstrated the safety and feasibility of 18F-FGln PET, showing uptake in various cancer types. More recent studies have shown its potential in specific applications, such as grading cerebral gliomas and guiding brain tumor biopsies. However, there are currently limited studies on the diagnostic value of 18F-FGln PET/CT across a broad spectrum of cancer types. Therefore, this prospective study was conducted to evaluate the diagnostic performance of 18F-FGln PET/CT in patients with various types of malignant tumors, using histopathological diagnosis as the gold standard.

Study Type

Observational

Enrollment (Estimated)

110

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 Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
        • 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

No

Sampling Method

Probability Sample

Study Population

This study will include patients from the Affiliated Cancer Hospital & Institute of Guangzhou Medical University who underwent an 18F-FGln PET/CT scan between October 2025 and January 2028 . Eligible participants are adult patients aged 18 to 70 years with suspected or histopathologically confirmed malignant tumors. Patients with non-malignant lesions, pregnant women, and those with incomplete medical records or missing histopathological reference standards will be excluded. Data will be collected by reviewing the institutional medical records and PET/CT imaging database.

Description

Inclusion Criteria:

  1. Patients with clinical suspicion or exclusion of primary or recurrent malignant tumors (such as glioma of the brain, liver cancer, gastric cancer, duodenal cancer, colorectal cancer, ovarian cancer, etc., where 18F-FDG is prone to false negatives and false positives)
  2. Patients undergoing tumor staging or evaluating treatment effect using 18F-FDG PET/CT or 18F-FGln PET/CT to determine the most appropriate treatment strategy
  3. Patients without other tumor history
  4. Patients with good compliance, providing informed consent, and able to follow the research protocol

Exclusion Criteria:

  1. pregnant or lactating patients or patients under 18 years old
  2. the subjects and their parents or legal representatives are unable or unwilling to provide written informed consent;
  3. patients with poor compliance, unable to tolerate or cooperate with PET/CT examinations.
  4. those who have undergone gastrointestinal barium meal examination within one week;
  5. other situations where the investigators consider it inappropriate for the subjects to participate in this clinical trial

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

Cohorts and Interventions

Group / Cohort
Patients with Malignant Tumors
Patients with suspected or histopathologically confirmed malignant tumors who underwent 18F-FGln PET/CT scan at the Affiliated Cancer Hospital & Institute of Guangzhou Medical University

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVMAX
Time Frame: Within one day after the PET/CT scan
Xingxiang's Chinese report system automatically delineates the areas of interest.
Within one day after the PET/CT scan
TBR
Time Frame: Within one day after the PET/CT scan
Xingxiang's Chinese report system automatically delineates the areas of interest.
Within one day after the PET/CT scan

Collaborators and Investigators

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

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

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)

October 20, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

May 16, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2025021-02

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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