NCT07087080Recruiting
Plasma Metabolomics as a Tool to Distinguish PET-positive Malignant From PET-positive Benign Nodules
Combining PET-CT With a Glutamate-based Blood Test Improves Cancer Diagnosis in Solitary Pulmonary Nodules
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 20 May 2025
- Start date
- 2 Mar 2022
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Hasselt University
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT07087080
What you commit to
- Study type: Interventional
- Planned participants: 350
- From 2 Mar 2022 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- no fasting starting 6h prior to blood sampling;
- medication intake on the morning of blood sampling;
Other illness
- history of cancer during the past five years;
- treatment for cancer during the past five years.
Lab values
- fasting blood glucose concentration is higher than 200 mg/dL in the morning of blood sampling;
Who the study is looking for
- patients who undergo a PET-CT scan at ZOL for a lung nodule, who are willing to provide written informed consent
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.