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临床试验/NCT01988272
NCT01988272已完成不适用

Imaging Based Dosimetry for Individualized Internal Emitter Therapy

University of Michigan1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Correlation between radiation absorbed dose to tumor and response or progression free survival

研究概览

简要总结

The goal of this study is to develop imaging based methods to accurately determine the energy absorbed (absorbed dose) by tumor tissue and bone marrow after radioimmunotherapy with I-131 tositumomab . The administration of the radioactive, iodine-131 labeled, monoclonal antibody I-131 tositumomab, (also known as Bexxar) is part of the patient's clinical treatment protocol. For the absorbed dose measurement, investigators at the University of Michigan are evaluating a new Nuclear Medicine SPECT/CT imaging system . This new camera combines a CT imaging system in addition to a Nuclear Medicine SPECT scanner. CT scans allow the doctors to see a high quality picture of your internal organs. The Nuclear Medicine SPECT scanner allows the doctors to see the uptake of the radioactive I-131 including the tumor sites. The improved imaging using the SPECT/CT enables more accurate calculation of the energy absorbed by tumor tissue and bone marrow. Using the results from these calculations and clinical follow up data, the researchers will investigate the relationship between the absorbed dose to the tumor and the patient's tumor response as well as the relationship between the absorbed dose to the bone marrow and the bone marrow toxicity. These relationships can potentially be used in the future by doctors to help determine how much radioactive I-131 to administer to each patient to get optimal results.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Clinically stable patients undergoing I-131 Tositumomab (Bexxar) for treatment of Non-Hodgkin Lymphomas

排除标准

  • • Clinical instability
  • Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed
  • Refusal to provide informed consent
  • Patients who are pregnant

结局指标

主要结局

Correlation between radiation absorbed dose to tumor and response or progression free survival

时间窗: 6 months

Tumor absorbed doses will be calculated based on research SPECT/CT imaging and correlated with the response as assessed by clinical PET/CT.

次要结局

  • Assess correlation between radiation absorbed dose to the bone marrow and hematologic toxicity.(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuni Dewaraja

Research Associate Professor

University of Michigan

研究点 (1)

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