Evaluating a new PET scan method for diagnosing low-grade gliomas
Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics as Biomarkers for the Improvement of Care of MRI Non-contrast Enhanced Gliomas
PHASE3 · Central Hospital, Nancy, France · NCT05512403
This study is testing a new type of PET scan to see if it can help doctors better identify aggressive low-grade brain tumors in patients who may not show clear signs on regular MRI scans.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT05512403 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of 18F-FDOPA PET kinetic parameters as diagnostic biomarkers for identifying aggressive low-grade gliomas (LGGs) that do not show contrast on MRI. The study aims to enhance patient care by providing a non-invasive method to distinguish between aggressive and non-aggressive forms of LGGs, which is crucial for timely treatment decisions. Participants will undergo PET/CT scans to assess the diagnostic performance of this imaging technique in a cohort of patients with suspected LGGs. The trial is designed to address the current lack of standardized management for these brain lesions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a unifocal brain tumor suspected to be a low-grade glioma and no contrast enhancement on MRI.
Not a fit: Patients with multifocal brain lesions or contraindications to 18F-FDOPA PET will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and timely treatment for patients with low-grade gliomas.
How similar studies have performed: While the use of PET imaging in glioma diagnosis is promising, this specific approach using 18F-FDOPA PET kinetics is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 75 years old * WHO general condition ≤2 * Identification of a unifocal brain tumour at the initial diagnosis with no contrast in the MRI and suspected to be a LGG, with biopsy/surgery envisaged within 6 months of the PET scan * MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR). * Subject affiliated to or beneficiary of a social security plan * Subject having received complete information on the organisation of the research and having signed the informed consent form. Exclusion Criteria: * Multifocal brain lesions * Contraindication to 18F-FDOPA PET * Pregnant, parturient women or nursing mothers under Article L1121-5 * Women of childbearing age who do not have effective contraception under Article L1121-5 * Monitoring not possible * Persons deprived of their liberty by a judicial or administrative decision under Article 1121-8, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1. * Patients cannot simultaneously participate in an interventional research trial for the duration of the KING study
Where this trial is running
Vandœuvre-lès-Nancy
- CHRU Nancy — Vandœuvre-lès-Nancy, France (RECRUITING)
Study contacts
- Principal investigator: Antoine VERGER, MD, PhD — CHRU Nancy
- Study coordinator: VERONIQUE ROCH, MSc
- Email: v.roch@chru-nancy.fr
- Phone: 0383154276
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.
Conditions: Glioma