Dose-Response in Radionuclide Therapy of Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Tumor Absorbed Dose
研究概览
简要总结
RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.
PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in treating patients with thyroid cancer.
详细描述
OBJECTIVES:
- Determine the relationship between estimated absorbed dose of iodine I 131 and tumor response or normal organ toxicity for different dosimetric measures, using data derived from clinical radionuclide therapy studies in patients with thyroid cancer.
OUTLINE: Patients receive oral dosimetric iodine I 131 (^131I) on day 2 and then undergo nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric ^131I. Single-photon emission computed tomography (SPECT)/CT scans are performed at 0.5-4 hours and 24 or 48 hours over the head and neck region, including the salivary glands. Subsequent SPECT/CT scans are performed over the candidate tumor sites. Patients undergo ^131I therapy on day 11.
Saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow rate. Blood is collected at baseline and periodically during study to measure FLT3 ligand levels.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of thyroid cancer
- •Measurable disease by CT scan or nuclear medicine imaging
- •Eligible, by standard of care criteria, for iodine I 131 therapy
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy)
- •No other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin
- •No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart Association class III or IV congestive heart failure or renal failure)
- •No alcoholism or drug abuse within the past 2 years
- •No severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia)
- •PRIOR CONCURRENT THERAPY:
- •No intravenous water-soluble radiographic contrast within the past 4 weeks
- •No iodinated contrast agent within the past 3 months
- •No concurrent drugs that may affect thyroid or renal function (e.g., renal drugs, lithium, amiodarone, other iodine-containing medication, or corticosteroids)
- •No other concurrent investigational drugs
排除标准
- 未提供
研究组 & 干预措施
Patient-specific 3D-RD Dosimetry
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
干预措施: Patient-specific dosimetry (Device)
结局指标
主要结局
Tumor Absorbed Dose
时间窗: up to 4 years
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
次要结局
未报告次要终点