跳至主要内容
临床试验/NCT02128945
NCT02128945已完成1 期

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

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Standardized measure of [18F]-Fludarabine uptake in tumor tissue.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Standardized measure of [18F]-Fludarabine uptake in tumor tissue.

时间窗: Day 0 ([18F]-Fludarabine PET-CT day)

Measure of the Standard Uptake Value (SUV) for each lesion.

次要结局

  • Calculation of the equivalent dose to all organs and evaluation of effective dose to the whole body(Day 0 ([18F]-Fludarabine PET-CT day))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验