Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
Information source: University Hospital, Caen
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Untreated B-Chronic Lymphocytic Leukemia or Diffuse Large B Cells Lymphoma Patients
Intervention: [18F] - Fludarabine PET/CT (Other)
Phase: Phase 1
Status: Recruiting
Sponsored by: University Hospital, Caen Official(s) and/or principal investigator(s): Sylvain P CHANTEPIE, MD, Principal Investigator, Affiliation: University Hospital, Caen
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.
Clinical Details
Official title: Dosimetry and Biodistribution of [18F]-Fludarabine in Lymphoid Malignancies
Study design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Standardized measure of [18F]-Fludarabine uptake in tumor tissue.
Secondary outcome: Calculation of the equivalent dose to all organs and evaluation of effective dose to the whole body
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University Hospital, Caen 14000, France; Recruiting Sylvain P Chantepie, MD, Phone: +33231272073, Email: chantepie-s@chu-caen.fr Sylvain P Chantepie, MD, Principal Investigator
Additional Information
Starting date: April 2014
Last updated: February 4, 2015
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