Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients Clinical Trial
— FLUDATEPOfficial title:
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | May 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen | CNRS, UMR ISTCT 6301, LDM-TEP Groupe, GIP Cyceron, Caen, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Distribution and temporal activity curve of [18F]-Fludarabine obtained for each organ and collection of possible adverse events. | Collection of every adverse events | Participants will be followed for a maximum of 9 days after [18F]-Fludarabine PET-CT. | Yes |
| Primary | Standardized measure of [18F]-Fludarabine uptake in tumor tissue. | Measure of the Standard Uptake Value (SUV) for each lesion. | Day 0 ([18F]-Fludarabine PET-CT day) | No |
| Secondary | Calculation of the equivalent dose to all organs and evaluation of effective dose to the whole body | Day 0 ([18F]-Fludarabine PET-CT day) | Yes |