Comparison of I-124 PET/CT to I-123 Whole Body Imaging for the Diagnosis of Thyroid
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Thomas Hope
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Proportion of agreement between I-124 PET and I-123/I-131 SPECT (participant)
研究概览
简要总结
Persons diagnosed with thyroid cancer are often treated initially with a thyroidectomy, which is followed by ablation using Iodine-131, a therapy which has been shown to be effective and safe. Imaging of metastatic thyroid cancer has been performed with whole body I-131 and Iodine 123 (I-123) imaging for many decades and use I-123 for staging studies. Iodine 124 (I-124) is a radioisotope of iodine which emits a positron and is imaged using PET (positron emission tomography). This is a single arm prospective trial that evaluates the ability of Iodine-124 (I-124) to detect metastatic thyroid cancer compared to non-interventional, usual care I-123 and I-131 images.
详细描述
PRIMARY OBJECTIVES:
1) Agreement between 1-124 PET and 1-123/1-131 SPECT.
SECONDARY OBJECTIVES:
- Sensitivity and specificity of I-124 PET to detect metastatic thyroid cancer compared to composite standard.
- Reclassification rate of I-124 PET compared to I-123 SPECT.
- Inter-reader variability for I-124 PET and I-123 SPECT.
- Safety of I-124 PET.
- Participant level detection rate for I-124 in the overall population.
- Participant level detection rate for I-124 in participants who have negative I-123 SPECT.
- Comparison of lesion detection between I-124 PET and 24 hour I-123 SPECT.
- Comparison of lesion detection between I-124 PET and post-treatment I-131 SPECT.
EXPLORATORY OBJECTIVES:
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 13 years.
- •Histopathologically confirmed differentiated or poorly differentiated thyroid cancer.
- •Meeting criteria for one of the following two populations:
- •American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on treatment using I-
- •Metastatic disease on imaging (CT, MRI, ultrasound or FDG PET), and considering localized therapy such as surgery and radiation therapy.
- •Undergone total thyroidectomy.
- •Planned I-123 imaging within 45 days after enrollment.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- •Known pregnancy.
研究组 & 干预措施
Intervention: I-124 PET/CT
All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed.
干预措施: Positron Emission Tomography (PET)/Computerized tomography (CT) (Procedure)
Intervention: I-124 PET/CT
All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed.
干预措施: Iodine-124 (Drug)
结局指标
主要结局
Proportion of agreement between I-124 PET and I-123/I-131 SPECT (participant)
时间窗: 1 day
Participant-level agreement between I-124 PET and the combination of I-123/I-131 SPECT will be measured. A participant will be classified as showing agreement only if all six regions demonstrate agreement; disagreement in one or more regions will result in a classification of disagreement. Positive percent agreement (PPA) and negative percent agreement (NPA) will be reported with corresponding 95% confidence intervals.
Number of agreement between 1-124 PET and 1-123/1-131 SPECT (region)
时间窗: 1 day
Region-level agreement between 1-124 PET and the combination of 1-123/1-131 SPECT will be determined by Individual reader and through a consensus read. A region is in agreement if I-124 PET and I-123/I-131 SPECT results align, either as true positive (both positive) or true negative (both negative). Disagreement occurs when the results diverge, categorized as false positive (I-124 PET positive, but I-123/I-131 SPECT negative) or false negative (I-124 PET negative, but I-123/I-131 SPECT positive).
次要结局
- Inter-reader reliability (IRR) for I-124 PET (region)(1 day)
- Inter-reader reliability (IRR) for I-124 PET (participant)(1 day)
- Proportion of participants with treatment-related adverse events(Up to 5 days)
- Proportion of participants with positive I-124 PET in the overall population(1 day)
- Proportion of participants with positive I-124 PET in participants who have negative I-123 SPECT(1 day)
- Mean of total number of lesions characterized as positive on I-124 PET and 24 hour I-123 SPECT(1 day)
- Mean of total number of lesions characterized as positive on both I-124 PET and 7-day post I-131(1 day)
- Overall specificity of I-124 PET for detection of metastatic thyroid cancer (participant)(1 day)
- Overall specificity of I-124 PET for detection of metastatic thyroid cancer (region)(1 day)
- Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (participant)(1 day)
- Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (region)(1 day)
- Intra-reader reliability (Intra-RR) for I-124 PET (participant)(1 day)
- Biodistribution of I-124 measured by standardized uptake value (SUV) in tumor and target organs(1 day)
- Overall specificity of I-124 PET to detect metastatic thyroid cancer (participant)(1 day)
- Overall specificity of I-124 PET to detect metastatic thyroid cancer (region)(1 day)
- Overall sensitivity of I-124 PET to detect metastatic thyroid cancer (participant)(1 day)
- Overall sensitivity of I-124 PET to detect metastatic thyroid cancer (region)(1 day)
- Reclassification Rate(1 day)
- Inter-reader reliability (IRR) for I-124 PET (participant)(1 day)
- Proportion of participants with treatment-related adverse events(Up to 5 days)
- Inter-reader reliability (IRR) for I-124 PET (region)(1 day)
- Proportion of participants with positive I-124 PET in the overall population(1 day)
- Mean of total number of lesions characterized as positive on both I-124 PET and 7-day post I-131(1 day)
- Proportion of participants with positive I-124 PET in participants who have negative I-123 SPECT(1 day)
- Mean of total number of lesions characterized as positive on I-124 PET and 24 hour I-123 SPECT(1 day)
研究者
Thomas Hope
Principal Investigator
University of California, San Francisco