Evaluation of 99mTc Sestamibi Scans In Patients Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Lesion Detection on 99mTc Sestamibi Study
研究概览
简要总结
This study is being done to see if the radioisotope 99mTc sestamibi scans can locate what is causing the elevated serum thyroglobulin in persons with differentiated thyroid cancer who have elevated serum thyroglobulin levels and negative diagnostic imaging tests.
This is for patients with:
- Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT thyroglobulin antibodies ,
- All NEGATIVE standard diagnostic clinical imaging studies (NSDCIS) = negative ultrasound (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography scan (18F-FDG PET) within the last 12 mos.
- If EDCIS (extensive diagnostic clinical imaging studies of 18F-sodium fluoride positron emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone scan (99mTc MDP), AND negative brain CT or magnetic resonance (MR) are performed, these are also negative.
Voluntary patients will have sestamibi scan performed in 4 phases:
Phase 1: receive an injection into their vein of a radioisotope called 99mTc sestamibi.
Phase 2: wait for 60 to 90 minutes in a waiting room
Phase 3: imaged lying face up on an imaging table while a camera passes around you from the top of the head to approximately the level of knees. This requires approximately 45 minutes
Phase 4: images will be reviewed by the nuclear medicine physician. This will take ~10-15 minutes. If additional images are required to clarify an image, then additional images of that area will be performed on the same camera or an alternate camera. As earlier, the additional images performed lying face up. These images require ~20-45 minutes. The patient will then be released.
The risk of this study is considered very low, and the potential benefits to the patient are considered very high.
详细描述
This study is being done to see if the radioisotope 99mTc sestamibi scans can locate what is causing the elevated serum thyroglobulin in persons with differentiated thyroid cancer who have elevated serum thyroglobulin levels and negative diagnostic imaging tests.
This is for patients with:
- Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT thyroglobulin antibodies ,
- All NEGATIVE standard diagnostic clinical imaging studies (NSDCIS), which includes all the following negative studies: ultrasound (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography scan (18F-FDG PET) within the last 12 mos.
- If NSDCIS and negative brain CT or magnetic resonance (MR) are performed and are negative, voluntary patients will have 99mTc sestamibi scan performed in 4 phases:
Phase 1: receive an injection into their vein of a radioisotope called 99mTc sestamibi.
Phase 2: wait for 60 to 90 minutes in a waiting room
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •Diagnosed with differentiated thyroid carcinoma;
- •At least one prior I-131 therapy, which may be remnant ablation, adjuvant treatment, and/or treatment of distant metastases,
- •Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT thyroglobulin antibodies ,
- •All NEGATIVE standard diagnostic clinical imaging studies (SDCIS) = negative ultrasound (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography scan (18F-FDG PET) within the last 12 mos.
- •If extensive diagnostic clinical imaging studies (EDCIS) of 18F-sodium fluoride positron emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone scan (99mTc MDP), AND brain CT or magnetic resonance (MR) are performed, these are also negative.
排除标准
- •< 18 years of age;
- •Pregnant or breast feeding
- •Any SDCIS or EDCIS that is positive and/or suggestive of recurrent and/or distant metastases secondary to DTC. If a study is indeterminate, this will be forwarded to a committee for review and resolution.
研究组 & 干预措施
99mTc sestamilbi
25 mCi 99mTc sestamibi intravenous injection, once. Then imaged for 45 minutes. More imaging might be required and this will be determined by a nuclear medicine physician onsite
干预措施: 99mTc sestamibi (Drug)
结局指标
主要结局
Lesion Detection on 99mTc Sestamibi Study
时间窗: 1 year
Any area of radioactivity will be graded by a team of two blinded nuclear medicine physicians to determine if the uptake focus is metastatic disease.
次要结局
未报告次要终点