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[18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study
EU CTIS ID: 2024-512758-62-00
What this study is testing
Characterize the cerebral distribution and [18F]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F]-Fludarabine
- 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
See the full eligibility 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
- Hypersensitivity to the active substance, to any of the excipients or to any of the components of [18F]-Fludarabine
- 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
- Traitement antérieur pour un lymphome primitif du système nerveux central
- 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)
- Treatment with dipyridamole
- Positive HIV serology
- Presence of another progressive pathology that is life-threatening in the short term
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.