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临床试验/NCT06028282
NCT06028282Enrolling By Invitation不适用

Post-RAI Therapy Dosimetry and Quality Assessment of Target Tissue Dosing

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
10
试验地点
1
主要终点
Staging Accuracy and Improved Clinical Patient Care

研究概览

简要总结

The goal of this clinical trial study is to(1) determine the tissue specific dose of I-131 taken up by residing thyroid issue in the thyroid bed post-RAI along with any other sites in the neck and mediastinum as well as (2) correlate the dose delivered to residual tissues in the neck with patient follow-up based clinical outcomes, biochemical and imaging data following RAI therapy in patients with well-differentiated thyroid cancer (DTC). The main question[s] it aims to answer are:

  • [question 1] How can obtained whole body and planar images more adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum?
  • [question 2] How can we obtain information on the dose taken up by the tumor remnant to know how much radionuclide actually went to the residual disease/tissue? Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items].

详细描述

In our current clinical practice, patients with well-differentiated thyroid cancer (DTC) who receive oral administration of radioiodine 1-131 (RAI) have whole body and planar images obtained 4-5 days post-treatment. These images often do not adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum. Further, no information about what dose taken up by the tumor remnant is obtained and thus we are unable to know how much radionuclide actually went to the residual disease/tissue.

Using single photon emission computed tomography (SPECT)/CT we will be able to better localize and evaluate disease/tissue remnant or distant iodine-avid metastatic disease. In addition, using Varian Velocity Theranostics Dosimetry suite of software applications, we will be able to do dosimetry on post-RAI therapy patients and be able to better correlate clinical outcomes with tumor absorbed dose in addition to provide quality improvement for the radioiodine ablation.

研究设计

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

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

  • All minorities
  • 18 years of age and older
  • Ability to give consent
  • Male or female
  • Differentiated thyroid cancer (DTC)
  • Previous total thyroidectomy
  • Has either:
  • local lymph node metastases
  • distant mediastinal/cervical metastases
  • lung or osseous metastases as seen on prior imaging studies

排除标准

  • Non-iodine avid disease
  • Under 18 years of age
  • Unable to give consent
  • Pregnant women, Non-viable neonates or neonates of uncertain viability.
  • Non-English-speaking patients

结局指标

主要结局

Staging Accuracy and Improved Clinical Patient Care

时间窗: 24 months

In addition to providing a thorough evaluation for any iodine-avid disease in the thyroid bed, neck soft tissues and mediastinum, a SPECT/CT with a high-energy collimator will help better assess the clinical stage of disease at the time of RAI treatment. Thus, better staging accuracy will be obtained and this will improve clinical patient management

次要结局

未报告次要终点

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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