[18F]-Fludarabine PET/MRI in Primary Central Nervous System Lymphoma

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method using a special substance called \[18F\]-Fludarabine to help diagnose and monitor primary central nervous system lymphoma (a type of cancer that occurs in the brain). The goal is to see how well this new imaging technique works in identifying areas of lymphoma in the brain compared to traditional methods. Researchers believe that \[18F\]-Fludarabine could provide clearer images, making it easier to spot and track the disease.

To participate in this trial, individuals must be at least 18 years old and have been newly diagnosed with high-grade central nervous system lymphoma, confirmed through medical tests. They should not have received prior treatment for this lymphoma and must have a noticeable mass in the brain that is at least 1 cm in size. Participants will undergo a PET-MRI scan, which is a combination of two imaging techniques that helps visualize the brain. It's important for patients to understand that they will need to stay still during the scan for about an hour and that certain health conditions or treatments may prevent them from participating. Overall, this trial aims to improve our understanding of brain lymphoma and how best to detect it.

Gender

ALL

Eligibility 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.