Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies (FLUDATEP)
|ClinicalTrials.gov Identifier: NCT02128945|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : September 14, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
[18F] - Fludarabine PET/CT
Other: [18F] - Fludarabine PET/CT
[18F] - Fludarabine PET/CT before treatment
- 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.
- 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) ]
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128945
|Caen, France, 14000|
|Principal Investigator:||Sylvain P CHANTEPIE, MD||University Hospital, Caen|