Actively Recruiting

Phase Not Applicable
All Genders
NCT07087080

Plasma Metabolomics as a Tool to Distinguish PET-positive Malignant From PET-positive Benign Nodules

Led by Hasselt University · Updated on 2025-07-31

350

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

Sponsors

H

Hasselt University

Lead Sponsor

Z

Ziekenhuis Oost-Limburg

Collaborating Sponsor

AI-Summary

What this Trial Is About

Positron emission tomography-computed tomography (PET-CT) is an important technique in lung cancer staging, where almost no lung lesion goes undetected. However, PET-CT often fails to discriminate between malignant and non-malignant PET-positive solitary pulmonary nodules (SPNs) with a specificity of only 23%. 40-50% of those patients are advised to repeat their CT after three to six months to follow up on their lesions' progression, delaying a clear and correct cancer diagnosis and subsequent therapy. In more than 10% of the patients with an SPN on the PET-CT scan, an uncertain lung cancer diagnosis based on the PET-positive lesion leads to surgery that appears to be unnecessary. This project aims to use the plasma glutamate concentration as a biomarker to complement PET-CT in the discrimination between malignant and non-malignant PET-positive SPNs. The investigators will validate a plasma glutamate determination by high- performance liquid chromatography (HPLC) since this test needs to be rapid, cheap, minimally invasive, and available in every hospital. In addition to the analysis of plasma glutamate, other plasma metabolites will be screened to check for other potential biomarkers to discriminate between malignant and non-malignant PET-positive SPNs. Together with the PET-CTs' basic parameters, a quick measurement of fasted plasma glutamate and potentially other biomarker levels right before undergoing a PET-CT scan will support a more rapid lung cancer diagnosis and treatment, resulting in less risk for disease progression. In conclusion, our approach will improve the accuracy of lung cancer diagnosis, and avoid unnecessary surgery.

CONDITIONS

Official Title

Plasma Metabolomics as a Tool to Distinguish PET-positive Malignant From PET-positive Benign Nodules

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for a PET-CT scan at ZOL for a lung nodule
  • Willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Not fasting for at least 6 hours before blood sampling
  • Taking medication on the morning of blood sampling
  • Fasting blood glucose higher than 200 mg/dL on the morning of blood sampling
  • History of cancer within the past five years
  • Cancer treatment within the past five years

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium, 3600

Actively Recruiting

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Research Team

J

Jill Meynen, Master degree

CONTACT

L

Liesbet Mesotten, prof. dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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