Skip to main content
OpenTrials
Completed

NCT Number: NCT02128945

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult over 18
  • Signed written informed consent
  • Untreated stage B or C chronic lymphocytic leukemia
  • Untreated diffuse large B-cell lymphoma
  • Eligible for PET-CT
  • The subject must be covered by a social security system

Exclusion criteria

  • Age under 18
  • Patients concurrently included in an investigational trial
  • Weight over 120 kg
  • pregnant women
  • active infectious disease
  • immune hemolytic anemia
  • patients with creatinine clearance < 30 ml/mn
  • corticosteroid therapy

Treatment and study plan

[18F] - Fludarabine PET/CT

Other

[18F] - Fludarabine PET/CT before treatment

Primary outcomes

  1. Standardized measure of [18F]-Fludarabine uptake in tumor tissue.

    Time frame: Day 0 ([18F]-Fludarabine PET-CT day)

    Measure of the Standard Uptake Value (SUV) for each lesion.

Secondary outcomes

  1. Calculation of the equivalent dose to all organs and evaluation of effective dose to the whole body

    Time frame: Day 0 ([18F]-Fludarabine PET-CT day)

Other outcomes

  1. Distribution and temporal activity curve of [18F]-Fludarabine obtained for each organ and collection of possible adverse events.

    Time frame: Participants will be followed for a maximum of 9 days after [18F]-Fludarabine PET-CT.

    Collection of every adverse events

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

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

Registry information

Acronym: FLUDATEP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 1, 2014
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.