Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients Clinical Trial
Official title:
Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
The application of positron emission tomography with lymphoproliferative diseases today
provides diagnostic and therapeutic information of major importance , especially in terms of
speed and quality of response to treatment. The radiopharmaceutical used in clinical
practice for this exam is fluorodeoxyglucose 18F-2-fluoro-2-deoxy-D-glucose
fluorodeoxyglucose ([18F]-FDG) . However , the uptake of this tracer is not elective in
lymphoid tissues , with a lack of specificity. In addition , the avidity of this tracer is
unequal according to the histological subtype (lack of sensitivity).
To try to improve the results of this clinical exploration of lymphoid malignancies, the
investigators developed a new radiopharmaceutical ( [18F] - fludarabine ). The idea of
transforming the fludarabine radiopharmaceutical is based on the existence of a fluorine
atom in the molecule and the pharmacokinetic characteristics of this drug. The
[18F]-Fludarabine is a new radiopharmaceutical reproducing the same dosage formulation of
fludarabine , a drug used for the treatment of certain types of lymphoproliferative
diseases, especially those where the tumor cells have a low proliferation kinetics . This
drug is used in therapy in particular pharmacokinetic effect for a high affinity for the
lymphoid tissue . Preclinical results on normal and lymphoma xenograft -bearing mice showed
a specificity restricted to lymphoid tissue fixation with [18F]-Fludarabine compared with
[18F]-FDG .
Based on these encouraging results , the investigators propose in this work to explore the
Dosimetry and Biodistribution of [18F] - Fludarabine in human lymphoproliferative diseases :
1)A first group of patients with non-Hodgkin's large cell lymphomas in which it already has
a wealth of experience in exploration [18F]-FDG, and 2) a second group of patients with
chronic lymphocytic leukemia, where the results of the exploration [18F]-FDG are considered
disappointing and did not, for this reason, experienced clinical development.
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Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic