Clinical trial NCT02128945: Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
Official title: Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients
Keywords: PET
Chronic lymphocytic Leukemia (CLL)
Diffuse Large B Cells Lymphoma (DLBCL)
Fludarabine
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: CNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, France
First posted: 2014-05-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Standardized measure of [18F]-Fludarabine uptake in tumor tissue.
timeFrame: Day 0 ([18F]-Fludarabine PET-CT day)
Secondary outcomes:
measure: Calculation of the equivalent dose to all organs and evaluation of effective dose to the whole body
timeFrame: Day 0 ([18F]-Fludarabine PET-CT day)
Other outcomes:
measure: Distribution and temporal activity curve of [18F]-Fludarabine obtained for each organ and collection of possible adverse events.
timeFrame: Participants will be followed for a maximum of 9 days after [18F]-Fludarabine PET-CT.
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Sylvain P CHANTEPIE, MD
role: PRINCIPAL_INVESTIGATOR
References: