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

March 30, 2026 updated by: University Hospital, Caen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FLUDATEP
[18F] - Fludarabine PET/CT
Other: [18F] - Fludarabine PET/CT
[18F] - Fludarabine PET/CT before treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 ([18F]-Fludarabine PET-CT day)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Day 0 ([18F]-Fludarabine PET-CT day)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed for a maximum of 9 days after [18F]-Fludarabine PET-CT.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

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

Investigators

  • Principal Investigator: Sylvain P CHANTEPIE, MD, University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimated)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-002796-18
  • 13-090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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