Using [18F]-Fludarabine PET/MRI to evaluate primary CNS lymphoma
[18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study
PHASE1 · Assistance Publique - Hôpitaux de Paris · NCT05390814
This study is testing a new imaging method using a special tracer to see if it can help doctors better detect primary brain lymphoma in patients who have just been diagnosed.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | chemotherapy, Fludarabine |
| Locations | 1 site (Paris) |
| Trial ID | NCT05390814 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the uptake of [18F]-Fludarabine in patients with newly diagnosed primary central nervous system lymphoma before they receive treatment. It involves a monocenter, open-label design where 16 patients will undergo PET/MRI imaging to characterize brain distribution and tumor uptake of the radiopharmaceutical. The study will also compare the results of [18F]-Fludarabine PET with various MRI techniques and histological diagnoses to evaluate its effectiveness in detecting lymphoma. The goal is to improve imaging specificity for CNS lymphomas compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed high-grade CNS lymphoma who have not yet received chemotherapy or radiotherapy.
Not a fit: Patients with previous treatment for primary CNS lymphoma or those with isolated primary vitreoretinal lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing and monitoring treatment response in patients with primary CNS lymphoma.
How similar studies have performed: While the use of [18F]-Fludarabine in imaging is novel, preclinical studies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥ 18 years * Diagnosis of newly diagnosed high-grade CNS lymphoma (with histological and/or cytological confirmation) * Patient naive to chemotherapy, or radiotherapy treatment for CNS lymphoma * Contrast-enhanced intracranial mass greater than or equal to 1 cm longest axis * Karnofsky index ≥ 40 * No systemic lymphoma on \[18F\]-FDG PET/CT * Creatinine clearance ≥ 30 mL/min * Social security affiliation (excluding AME) * Signature of the informed consent by the patient or by a legal representative or the close relative if the patient is not able to do so Exclusion Criteria: * Hypersensitivity to the active substance, to any of the excipients or to any of the components of \[18F\]-Fludarabine * Previous treatment for primary central nervous system lymphoma * Isolated primary vitro-retinal lymphoma * Isolated CNS relapse of a systemic lymphoma * Other active cancer except basal cell carcinoma of the skin and/or cervical cancer in situ * Immunosuppression (organ transplant in particular) * Positive HIV serology * Presence of another progressive pathology that is life-threatening in the short term * Treatment with dipyridamole * History of allergy to gadolinium chelates (DOTAREM®) * Absolute contraindication to MRI (pacemaker, cochlear implant ...), to the administration of gadolinium * Patient of childbearing potential without effective contraception, breastfeeding or pregnant * Severe cognitive impairment incompatible with good cooperation in the PET-MRI examination * Patient with pain or restlessness unable to remain motionless in supine position for 60 minutes * Weight \> 100 Kg * Patient deprived of liberty or under legal protection (guardianship or curatorship) * Ongoing participation in another interventional research protocol. Participation in research of a non-interventional type is authorized.
Where this trial is running
Paris
- Hôpital Pitié Salpêtrière — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Aurélie KAS, Pr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Aurélie KAS, Pr
- Email: aurelie.kas@aphp.fr
- Phone: 01 42 17 62 81
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: Primary Central Nervous System Lymphoma, [18F]-Fludarabine, PET-MRI, Primary Central Nervous System Lymphomas