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NCT Number: NCT07602569

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, China

Location status: Recruiting

Location contact

Rusen Zhang

CONTACT

[email protected]

0086-13642328295

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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
  • Patients without other tumor history
  • Patients with good compliance, providing informed consent, and able to follow the research protocol

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. SUVMAX

    Time frame: Within one day after the PET/CT scan

    Xingxiang's Chinese report system automatically delineates the areas of interest.

  2. TBR

    Time frame: Within one day after the PET/CT scan

    Xingxiang's Chinese report system automatically delineates the areas of interest.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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