A Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Radioiodide accumulation
研究概览
简要总结
This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of 10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and methimazole (impedes organification). Tumor, organ and whole body dosimetry will be calculated in each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage I-IV breast cancer. Patients must have clinical or radiographic evidence of localized or metastatic disease.
- •Criteria for NIS-positivity are defined as: >= 20% of cells with plasma membrane and/or strong intracellular/plasma membrane immunoreactivity
- •Any previous therapy including radiation therapy is allowable.
- •Women 18 years of age or older.
- •Patients must have a life expectancy of at least 3 months
- •Patients with ECOG Performance Status 0-3 will be eligible.
- •If on chemotherapy, thyroid suppression should be initiated no sooner than two weeks after last chemotherapy cycle.
- •Ability to understand and willingness to sign a written informed consent document.
- •Discontinuation of hormonal or biological therapies for the 10 days of the study is preferred but not mandated.
- •Laboratory tests (CBC, comprehensive metabolic panel) must be performed within 120 day prior to study initiation.
排除标准
- •History of metastatic thyroid cancer
- •Exclude the use of cytotoxic, hormonal or biological agents for one week prior to and during imaging.
- •Pregnant or nursing patients will be excluded from the study as iodide can accumulate in the breast and is transported across the placenta.
- •Inability to tolerate thyroid hormone and/or methimazole pre-imaging treatment.
- •History of thyroid cancer (because patient could have concomitant thyroid cancer metastases and therefore competitively concentrate radioiodides)
- •Psychiatric or addictive disorders that are not adequately controlled and would preclude obtaining informed consent.
- •Patients with heart disease or other significant cardiac risk factors will be excluded from receiving thyroid suppressive therapy so as to avoid precipitating a cardiac arrhythmia.
研究组 & 干预措施
Iodine-124 PET-CT scan
干预措施: Iodine-124 (Drug)
Iodine-124 PET-CT scan
干预措施: PET/CT with Iodine-124 (Radiation)
结局指标
主要结局
Radioiodide accumulation
时间窗: 2 years
To evaluate radioiodide accumulation in women with immunohistochemically NIS (Na+/I- symporter)-positive breast cancers using 124I PET/CT.
次要结局
- Dosimetry(2 years)
研究者
Irene L. Wapnir
Associate Professor
Stanford University