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RECRUITING
NCT07087080
NA

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

Sponsor: Hasselt University

View on ClinicalTrials.gov

Summary

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.

Official title: Combining PET-CT With a Glutamate-based Blood Test Improves Cancer Diagnosis in Solitary Pulmonary Nodules

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2022-03-02

Completion Date

2027-11-01

Last Updated

2025-07-31

Healthy Volunteers

No

Interventions

OTHER

Blood sampling

Single blood sampling (16 ml) after study inclusion before undergoing the PET-CT scan

Locations (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium