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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02128945
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : September 14, 2016
CNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, France
Information provided by (Responsible Party):
University Hospital, Caen

Brief 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.

Condition or disease Intervention/treatment Phase
Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients Other: [18F] - Fludarabine PET/CT Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02128945

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University Hospital
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen
CNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, France
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Principal Investigator: Sylvain P CHANTEPIE, MD University Hospital, Caen
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Responsible Party: University Hospital, Caen Identifier: NCT02128945    
Other Study ID Numbers: 2013-002796-18
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: January 2016
Keywords provided by University Hospital, Caen:
Chronic lymphocytic Leukemia (CLL)
Diffuse Large B Cells Lymphoma (DLBCL)
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents