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

NCT07087080 | Recruiting

• 1 other identifier: 2020/12375/1
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solitary Pulmonary Nodules; Lung Cancer

Keywords

Pulmonary nodules; Lung cancer; Plasma metabolomics; 1H-NMR; HPLC

Outcome Measures

Primary Outcomes (1)

• Fasted glutamate concentration

  Fasted glutamate, measured by High-Performance Liquid Chromatography (HPLC), will serve as metabolic biomarker in distinguishing between malignancy and non-malignancy in positron-emission tomography (PET) positive solitary pulmonary nodules (SPNs). To this end, fasted plasma glutamate concentration will be compared between patients with a final diagnosis of malignant and non-malignant PET-positive SPNs. Based on this, plasma glutamate cut-off values will be determined between the two groups of patients. Combining these cut-off values with PET-parameters can eventually increase the specificity of PET-CT.

  baseline

Secondary Outcomes (2)

• Screening of 61 measurable plasma metabolites

  baseline

• Combine metabolite values to radiomics features

  baseline

Study Arms (1)

Blood sampling

OTHER

Blood sampling

Other: Blood sampling

Interventions

Blood sampling OTHER

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

Blood sampling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who undergo a PET-CT scan at ZOL for a lung nodule, who are willing to provide written informed consent

You may not qualify if:

• no fasting starting 6h prior to blood sampling;
• medication intake on the morning of blood sampling;
• fasting blood glucose concentration is higher than 200 mg/dL in the morning of blood sampling;
• history of cancer during the past five years;
• treatment for cancer during the past five years.

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Related Publications (2)

• Vanhove K, Giesen P, Owokotomo OE, Mesotten L, Louis E, Shkedy Z, Thomeer M, Adriaensens P. The plasma glutamate concentration as a complementary tool to differentiate benign PET-positive lung lesions from lung cancer. BMC Cancer. 2018 Sep 3;18(1):868. doi: 10.1186/s12885-018-4755-1.

  PMID: 30176828 BACKGROUND

• Derveaux E, Geubbelmans M, Criel M, Demedts I, Himpe U, Tournoy K, Vercauter P, Johansson E, Valkenborg D, Vanhove K, Mesotten L, Adriaensens P, Thomeer M. NMR-Metabolomics Reveals a Metabolic Shift after Surgical Resection of Non-Small Cell Lung Cancer. Cancers (Basel). 2023 Apr 3;15(7):2127. doi: 10.3390/cancers15072127.

  PMID: 37046788 BACKGROUND

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms; Multiple Pulmonary Nodules

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Liesbet Mesotten, prof. dr.

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

• Jill Meynen

  Hasselt University

  STUDY CHAIR

• Elien Derveaux, dr.

  Hasselt University

  STUDY CHAIR

• Wouter Marchal, prof. dr.

  Hasselt University

  STUDY CHAIR

Central Study Contacts

Jill Meynen, Master degree

CONTACT

003289804034; jill.meynen@uhasselt.be

Liesbet Mesotten, prof. dr.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: 16 mL blood will be sampled from each participant before undergoing the PET/CT scan.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: July 25, 2025
• Study Start: March 2, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

BE (1)