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

Description:

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 (PET-\[18F\]-FDG) is the gold standard for imaging systemic lymphomas, but its application in primary CNS lymphoma is compromised by the limited specificity of brain fixations and the high uptake of \[18F\]-FDG in healthy brain tissue. \[18F\]-Fludarabine is a new radiopharmaceutical developed for PET imaging of lymphomas. Preclinical studies indicate a restricted binding specificity to lymphoid tissue compared to \[18F\]-FDG and an ability to detect residual lymphoma disease after treatment. A pilot study in humans shows good agreement of its binding with tumor sites in systemic lymphoma and superior tumor contrast to \[18F\]-FDG. Finally, a recent preclinical study shows a binding ratio in brain lymphoma 3 times higher than that of healthy brain tissue in mouse models of primary CNS lymphoma, whereas in mouse models of high-grade glial tumors, the binding level is very low, comparable to that of healthy tissue (background). Investigators hypothesize that \[18F\]-Fludarabine could be the radiopharmaceutical of choice for the diagnosis and monitoring of primary CNS lymphomas in PET. The main objective of the study is to characterize the cerebral distribution and \[18F\]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.

Sponsor:

Assistance Publique - Hôpitaux de Paris

Phase:

Phase 1

Contacts:

Aurélie KAS, Pr (PRINCIPAL_INVESTIGATOR)

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Fludarabine

Isotope(s):
Target(s):
  • dCK
Ligand Class: Small Molecules
Inclusion
  • Contrast-enhanced intracranial mass greater than or equal to 1 cm longest axis
  • Patient naive to chemotherapy, or radiotherapy treatment for CNS lymphoma
  • Diagnosis of newly diagnosed high-grade CNS lymphoma (with histological and/or cytological confirmation)
  • * Patients aged ≥ 18 years
  • Karnofsky index ≥ 40
Exclusion
  • Other active cancer except basal cell carcinoma of the skin and/or cervical cancer in situ
  • Isolated primary vitro-retinal lymphoma
  • Isolated CNS relapse of a systemic lymphoma
  • Previous treatment for primary central nervous system lymphoma
  • * Hypersensitivity to the active substance, to any of the excipients or to any of the components of \[18F\]-Fludarabine