Plasma glutamate blood test to help tell cancerous from non-cancerous PET-positive lung nodules
Combining PET-CT With a Glutamate-based Blood Test Improves Cancer Diagnosis in Solitary Pulmonary Nodules
This project will test whether a blood test that measures plasma glutamate can help people with PET-positive solitary pulmonary nodules find out if their nodule is cancerous.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT07087080 on ClinicalTrials.gov |
What this trial studies
Researchers will collect fasting blood samples from patients undergoing PET-CT for a lung nodule at Ziekenhuis Oost-Limburg and measure plasma glutamate using high-performance liquid chromatography (HPLC). Glutamate levels will be compared between patients whose nodules are confirmed malignant and those confirmed benign by pathology or follow-up imaging. Patients who have eaten within six hours, have very high fasting glucose, are on morning medications that affect metabolism, or have had cancer or cancer treatment in the past five years are excluded. The aim is to validate plasma glutamate as a metabolomics biomarker to complement PET-CT and improve diagnostic specificity for PET-positive solitary pulmonary nodules.
Who should consider this trial
Good fit: Ideal candidates are adults at Ziekenhuis Oost-Limburg who have a PET-positive solitary pulmonary nodule, can fast for six hours before blood sampling, and have no history or treatment for cancer in the past five years.
Not a fit: People who do not fast for six hours, have fasting blood glucose over 200 mg/dL, take morning medications that affect metabolism, have had cancer or cancer treatment in the past five years, or cannot attend the Genk site are unlikely to benefit.
Why it matters
Potential benefit: If successful, this blood test could reduce delays, unnecessary follow-up scans, and avoid some unnecessary surgeries by helping doctors distinguish malignant from benign PET-positive lung nodules sooner.
How similar studies have performed: Metabolomics approaches have shown promise in cancer detection, but using plasma glutamate measured by HPLC to distinguish PET-positive benign versus malignant SPNs is a relatively novel approach that is not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (Recruiting)
Study contacts
- Principal investigator: Liesbet Mesotten, prof. dr. — Ziekenhuis Oost-Limburg
- Study coordinator: Jill Meynen, Master degree
- Email: jill.meynen@uhasselt.be
- Phone: 003289804034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.