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临床试验/NCT01399931
NCT01399931Unknown不适用

Dual Point Acquisition in the Interim Pet Scan Performed During ABVD Treatment, in Early-Stage Hodgkin's Lymphoma Patients With Bulky Lesions

Ospedale Santa Croce-Carle Cuneo6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
6
主要终点
Event free survival (EFS)

研究概览

简要总结

To assess specificity and overall accuracy of interim dual-point acquisition PET in predicting treatment outcome.

The study is aimed at assessing the specificity of interim dual-point PET performed after 2 ABVD cycles to predict treatment outcome in early-stage Hodgkin's Lymphoma patients presenting bulky lesions at baseline.

详细描述

The proposed study is an non-interventional survey of a cohort of patients in whom interim PET scan is performed only for prognostic aims.

PET with 18F-FDG is a standard staging procedure for most lymphoma subtypes. Performed early during the therapy for Hodgkin's lymphoma (HL) its results have a high prognostic value and is the main predictor of treatment outcome. From 2006 onward, interim-PET after 2 ABVD courses has been increasingly performed in the daily clinical practice as a routine test for disease prognosis, and now it can be considered as a standard prognostic tool.

The novelty of the study relies on a new method for interim-PET scan execution: a dynamic study, with 2 different time points of image acquisition. This could potentially enable us to discriminate between unspecific, inflammatory DG uptake, from a "true" uptake form persisting viable neoplastic cells. Therefore, the main aim of the study is reducing false positive results in the interim-PET scan interpretation. Since dynamic changes of FDG uptake in Hodgkin's lymphoma are still unknown we propose, in the present study, to assess the by the same acquisition technique the pattern of FDG uptake at baseline in untreated patients affected by this neoplasm.

The Institutions equipped with a Magnetic Resonance scanners and a diffusion weighted imaging analysis technique (DW-MRI), could participate to the DW-MRI sub-study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Hodgkin lymphoma diagnosis according all the WHO classification subtype but lymphocyte predominance.
  • Age 18 - 60 years old
  • stage IA- IIA (by FDG-PET scan)
  • Presence of bulky tumour (either in Mediastinum or other site)
  • Treatment with ABVD x 4 (early stage)
  • Consolidation Radiotherapy on bulky lesion
  • Signed the Informed consent form

排除标准

  • Diabetes mellitus uncompensated
  • Lymphocyte predominance histology
  • Pregnancy or lactation
  • Implanted biomedical devices (for DW-MRI sub study)

结局指标

主要结局

Event free survival (EFS)

时间窗: 1 year

To assess feasibility of using interim dual-point acquisition PET in real world of clinical practice as well as describing the outcome of early stage HL patients.

次要结局

  • Evaluation of inflammation markers prognostic role(3 years)

研究者

发起方
Ospedale Santa Croce-Carle Cuneo
申办方类型
Other
责任方
Principal Investigator
主要研究者

DR. ANDREA GALLAMINI

HEAD OF HAEMATOLOGY DEPT. A.S.O. S. CROCE AND CARLE

Ospedale Santa Croce-Carle Cuneo

研究点 (6)

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