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

NCT05390814 | Completed Phase 1

• 2 other identifiers: P1604072021-005193-26
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Primary Central Nervous System Lymphoma

Keywords

[18F]-Fludarabine; PET-MRI; Primary Central Nervous System Lymphomas

Outcome Measures

Primary Outcomes (1)

• Measurements of [18F]-Fludarabine uptake in tumoral lesions and normal tissue using SUV, tumor/normal tissues ratios

  Standardized measurement of \[18F\]-Fludarabine uptake (SUV) in tumor will be done on PET imaging superimposed on post gadolinium MRI.

  15 days

Secondary Outcomes (7)

• Cerebral distribution of [18F]-Fludarabine in healthy and tumoral tissues

  15 days

• Temporal activity curves of [18F]-Fludarabine in healthy and tumoral tissues

  15 days

• Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG

  15 days

• Volumes of contrast enhancement in post-gadolinium T1-weighted MR sequence

  15 days

• Hypersignal in diffusion-weighted sequence and apparent diffusion coefficient (ADC)

  15 days

Study Arms (1)

PET-RMI

EXPERIMENTAL

Drug: PET-MRI

Interventions

PET-MRI DRUG

\[18F\]-Fludarabine imaging in the diagnostic workup of primary central nervous system lymphomas: a PET-MRI pilot study

PET-RMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Study Officials

• Aurélie KAS, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: December 18, 2023
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)