Status:
COMPLETED
[18F]-Fludarabine PET/MRI in Primary Central Nervous System Lymphoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Primary Central Nervous System Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary central nervous system (CNS) lymphomas represent 5% of primary brain tumors. More than 90% of them are diffuse large B-cell lymphomas. \[18F\]-Fluorodeoxyglucose positron emission tomography ...
Detailed Description
Monocenter, open, uncontrolled and non-randomized pilot study designed to evaluate the uptake of \[18F\]-Fludarabine in 16 patients with newly diagnosed CNS lymphoma at initial diagnosis, before treat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05390814
Start Date
December 18 2023
End Date
December 5 2024
Last Update
August 22 2025
Active Locations (1)
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1
Hôpital Pitié Salpêtrière
Paris, France, 75013