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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512758-62-00
Acronym
P160407
Enrollment
16
Registered
2024-11-08
Start date
2023-12-18
Completion date
2024-12-05
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with newly diagnosed primary central nervous system lymphoma naïve to surgery, radiotherapy or chemotherapy

Brief summary

Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI.

Detailed description

Cerebral distribution and activity-time curves for [18F]-Fludarabine, Tumor/healthy tissue contrast on PET-[18F]-Fludarabine, Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG, lesion volumes in 3D T1 MRI with Gadolinium, Apparent diffusion coefficient (ADC) in diffusion MRI, Tumor perfusion in perfusion MRI, Metabolite ratios in spectroscopy, histological or cytological diagnosis

Interventions

DRUG[18F]fludarabine

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Standardized measurement of tumor uptake of [18F]-Fludarabine (Standard uptake value or SUV) in tumor lesions, relative to SUV of healthy tissue quantified on PET images superimposed on MRI.

Secondary

MeasureTime frame
Cerebral distribution and activity-time curves for [18F]-Fludarabine, Tumor/healthy tissue contrast on PET-[18F]-Fludarabine, Tumor SUVmax, tumor/healthy tissue ratio in PET- [18F]-FDG, lesion volumes in 3D T1 MRI with Gadolinium, Apparent diffusion coefficient (ADC) in diffusion MRI, Tumor perfusion in perfusion MRI, Metabolite ratios in spectroscopy, histological or cytological diagnosis

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026