MedTrace Logo

Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies

NCT02128945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-02

No results posted yet for this study

Summary

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.

Conditions

  • Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients

Interventions

OTHER

[18F] - Fludarabine PET/CT

\[18F\] - Fludarabine PET/CT before treatment

Sponsors & Collaborators

  • CNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, France

    collaborator UNKNOWN

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Sylvain P CHANTEPIE, MD · University Hospital, Caen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02128945 on ClinicalTrials.gov