NCT07087080 Plasma Metabolomics as a Tool to Distinguish PET-positive Malignant From PET-positive Benign Nodules
| NCT ID | NCT07087080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hasselt University |
| Condition | Solitary Pulmonary Nodules |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2022-03-02 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * patients who undergo a PET-CT scan at ZOL for a lung nodule, who are willing to provide written informed consent Exclusion Criteria: * 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.
Contact & Investigator
Liesbet Mesotten, prof. dr.
PRINCIPAL INVESTIGATOR
Ziekenhuis Oost-Limburg
Frequently Asked Questions
Who can join the NCT07087080 clinical trial?
This trial is open to participants of all sexes, studying Solitary Pulmonary Nodules. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07087080 currently recruiting?
Yes, NCT07087080 is actively recruiting participants. Contact the research team at jill.meynen@uhasselt.be for enrollment information.
Where is the NCT07087080 trial being conducted?
This trial is being conducted at Genk, Belgium.
Who is sponsoring the NCT07087080 clinical trial?
NCT07087080 is sponsored by Hasselt University. The principal investigator is Liesbet Mesotten, prof. dr. at Ziekenhuis Oost-Limburg. The trial plans to enroll 350 participants.