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临床试验/NCT00003337
NCT00003337Unknown3 期

The Utility of LymphoScan Imaging in the Localization and Staging of Patients With Non-Hodgkin's Lymphoma

Gilead Sciences16 个研究点 分布在 5 个国家目标入组 100 人开始时间: 1997年3月最近更新:
适应症

试验速览

阶段
3 期
入组人数
100
试验地点
16

研究概览

简要总结

RATIONALE: Diagnostic imaging procedures using radiolabeled monoclonal antibodies may improve the ability to detect and stage non-Hodgkin's lymphoma.

PURPOSE: Phase III trial to study the effectiveness of a radiolabeled monoclonal antibody in the detection and staging of patients with non-Hodgkin's lymphoma.

详细描述

OBJECTIVES: I. Determine the radioimmunodetection performance of the imaging agent technetium Tc 99m LL2 monoclonal antibody (LymphoScan) in patients with low, intermediate, and high grade B-cell non-Hodgkin's lymphoma. II. Define the safety of an initial administration of technetium Tc 99m LL2 monoclonal antibody in these patients. III. Demonstrate that diagnostic imaging with this agent can correctly stage patients who have been diagnosed with this disease similarly to noninvasive conventional diagnostic modalities (CDMs), primarily CT scan and bone scan. IV. Demonstrate that imaging with technetium Tc 99m LL2 monoclonal antibody is at least as sensitive for detecting disease in various body sites as any other standard diagnostic imaging method. V. Compare patient management plans based on CDMs alone, technetium Tc 99m LL2 monoclonal antibody alone, and both CDMs and technetium Tc 99m LL2 monoclonal antibody. VI. Describe the human antimouse antibody production in these patients.

OUTLINE: This is an open label, multicenter study. After all other diagnostic studies have been completed, patients receive an infusion of technetium Tc 99m LL2 monoclonal antibody by IV injection or infused over 20-30 minutes as part of their staging procedures. Planar images are acquired between 4-8 hours and 18-24 hours following antibody injection, and single photon emission computerized tomography (SPECT) imaging is performed between 4-8 hours following antibody injection. Patients may receive a repeat injection of technetium Tc 99m LL2 monoclonal antibody. Patients are followed for 3 to 6 months.

PROJECTED ACCRUAL: At least 100 patients will be accrued into this study.

研究设计

研究类型
Interventional
主要目的
Diagnostic

入排标准

年龄范围
16 Years 至 120 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Industry

研究点 (16)

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