此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Diagnostic Utility of [18F]-FDG-PET/CT and [124I]-PET/CT for Detection of Recurrence in Differentiated Thyroid Carcinoma

2011年6月15日 更新者:Korean Association of Endocrine Surgeons

Effectiveness of [124I]-PET/CT and [18F]-FDG-PET/CT for Localizing Recurrence in Patients With Differentiated Thyroid Carcinoma Who Have Elevated Serum Thyroglobulin Levels But Are Tumor-negative on Conventional Imaging Studies

Several studies have indicated that [124I]-PET/CT or [18F]-FDG-PET/CT may be useful to locate recurrent differentiated thyroid carcinoma lesions in patients with elevated thyroglobulin levels but who do not show pathological lesions when conventional imaging modalities are used. Thus, the investigators evaluated the effectiveness of PET/CT using both [124I] and [18F]-FDG in such patients.

研究概览

地位

未知

详细说明

<Inclusion Criteria> Patients with histologically proven DTC were studied. All patients had previously undergone total thyroidectomy and more than one session of postoperative RI therapy. More than 12 months of follow-up after the last RI therapy session, all patients showed increasing pathological Tg levels (Tg > 9-10 ng/ml) after TSH stimulation (TSH > 30 mU/l). However, neither tumor recurrence nor metastasis could be detected in any patient by post-therapeutic [131I] scanning, neck US, or chest radiography. Patients with obvious cervical pathology or positive fine-needle aspiration cytology (FNAC) were excluded from the study. The work was approved by our Institutional Review Board and written informed consent was obtained from each patient.

<Study protocol> The study was prospectively designed to evaluate the diagnostic efficacies of [18F]-FDG-PET/CT and [124I]-PET/CT in patients with elevated Tg levels, but who yielded no pathological findings on conventional imaging. The [124I] radioisotope was supplied by the Radiopharmaceutical Research Team of the Korea Institute of Radiological and Medical Sciences (KIRAMS). All involved patients underwent a diagnostic [131I] scan, [18F]-FDG-PET/CT, and [124I]-PET/CT. On the first day (D1) of the study, blood and urine were collected for routine examination; to measure blood TSH, Tg, and anti-Tg antibody levels; and to assess urine iodine excretion after 4 weeks of levothyroxine (LT4) withdrawal. All patients had consumed a low-iodine diet for the prior 2 weeks, following written instructions and assisted by a dietician. On the second day (D2) of the study, an [131I] scan was obtained 48 h after administration of 74 MBq of [131I]. On day 10 (D10) of the study, patients fasted for at least 4 h before examination, and were (intravenously) given 370 MBq [18F]-FDG. All patients were instructed to rest comfortably for 60 min and to empty the bladder before scanning. Whole-body PET/CT images were obtained using a Discovery ST scanner (GE Healthcare, Milwaukee, WI). Seven or eight frames (3 min/frame) of emission PET data were acquired in the two-dimensional mode after noncontrast CT scans had been performed from the base of the skull to the upper thigh (tube rotation time of 1 s per revolution; 120 kV; 60 mA; 7.5 mm per rotation; and an acquisition time of 60.9 s for a scan length of 867 mm). Emission PET images were reconstructed via non-contrast CT using an iterative method (ordered-subsets expectation maximization with two iterations and 30 subsets; field of view 600 mm; slice thickness 3.27 mm). Attenuation-corrected PET/CT images were reviewed on an Xeleris workstation (GE Healthcare). All images were independently interpreted by two experienced nuclear medicine physicians and screened for "hot spots" indicative of hypermetabolic abnormalities.

On day 11 (D11) of the study, 24 h after administration of an [124I] trace dose (74 MBq), whole-body PET/CT scans were obtained using the Discovery ST scanner. First, a non-enhanced CT scan was performed, from the base of the skull to the upper thigh (tube rotation time of 1 s per revolution; 140 kV; 80 mA; 3.75 mm per rotation; acquisition time of 23.9 s for a scan length of 804 mm). Subsequently, seven or eight frames (5 min per frame) of emission PET data were acquired in the two-dimensional mode and reconstructed via CT using an iterative method (software from General Electric Medical Systems; ordered-subsets expectation maximization with two iterations and 21 subsets; field of view 600 mm; slice thickness 3.27 mm).

<Data analysis> To ensure that the interpretation of [18F]-FDG-PET/CT and [124I]-PET/CT data was performed under similar conditions, all physicians who initially read images of one type were deliberately blinded to the results of the other type of imaging, and to patient clinical data. This was achieved by ensuring that the interpreting physicians were not involved in patient clinical care. Findings on [18F]-FDG-PET and [124I]-PET scanning were compared with data from diagnostic and post-therapeutic [131I] scans. Moreover, the data were compared with those of radiological imaging (US, CT, and MRI information), and/or those of cytological investigation (FNAC), to confirm (or otherwise) the findings of the [131I] scans, and those of both forms of PET/CT (using [18F]-FDG and [124I]). For each patient, the presence or absence, and number and localization of any recurrent lesions (if present) were determined. The data of both types of PET/CT scans were classified as follows: 1) True-positive, if pathologic [18F]-FDG or [124I] uptake was proven by histology, cytology, or other imaging techniques, and caused therapy to be changed; 2) False-positive, if no pathologic [18F]-FDG or [124I] uptake was seen (such observations were of no clinical consequence); 3) True-negative, if no [18F]-FDG or [124I] uptake was found and the patient had neither an elevated Tg level nor any evidence of recurrence upon subsequent follow-up; and, 4) False-negative if no [18F]-FDG or [124I] uptake was noted despite elevated Tg levels, even if positive findings were obtained when other imaging methods were employed.

研究类型

观察性的

注册 (预期的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 至 85年 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Study patients who underwent total thyroidectomy with more than one of high dose radioactive iodine treatment, showed elevated Tg levels, but who yielded no pathological findings on conventional imaging during follow-up period.

描述

Inclusion Criteria:

  • Study patients with histologically proven DTC were studied. All patients had previously undergone total thyroidectomy and more than one session of postoperative RI therapy.During follow-up after the last RI therapy session, all patients showed increasing pathological Tg levels (Tg > 9-10 ng/ml) after TSH stimulation (TSH > 30 mU/l). However, neither tumor recurrence nor metastasis could be detected in any patient by post-therapeutic [131I] scanning, neck US, or chest radiography.

Exclusion Criteria:

  • Patients with obvious cervical pathology or positive fine-needle aspiration cytology (FNAC) were excluded from the study. The work was approved by our Institutional Review Board and written informed consent was obtained from each patient.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Study patients
Study patients with histologically proven DTC were studied. All patients had previously undergone total thyroidectomy and more than one session of postoperative RI therapy. After the last RI therapy session, all patients showed increasing pathological Tg levels (Tg > 9-10 ng/ml) after TSH stimulation (TSH > 30 mU/l). However, neither tumor recurrence nor metastasis could be detected in any patient by post-therapeutic [131I] scanning, neck US, or chest radiography. Patients with obvious cervical pathology or positive fine-needle aspiration cytology (FNAC) were excluded from the study. The work was approved by our Institutional Review Board and written informed consent was obtained from each patient.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnostic values of [124I]-PET/CT and [18F]-FDG-PET/CT imaging
大体时间:Follow up in more than 10 months after treatment
1) True-positive, if pathologic [18F]-FDG or [124I] uptake(;PET-uptake) was proven by histology, cytology, or other imaging techniques, and caused therapy to be changed; 2) False-positive, if no pathologic PET-uptake was seen; 3) True-negative, if no PET-uptake was found and the patient had neither an elevated Tg level nor any evidence of recurrence upon subsequent follow-up; and, 4) False-negative if no PET-uptake was noted despite elevated Tg levels, even if positive findings were obtained when other imaging methods were employed.
Follow up in more than 10 months after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jandee Lee, MD、Korean Association of Endocrine Surgeons

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年7月1日

初级完成 (实际的)

2011年6月1日

研究完成 (预期的)

2012年8月1日

研究注册日期

首次提交

2011年6月15日

首先提交符合 QC 标准的

2011年6月15日

首次发布 (估计)

2011年6月16日

研究记录更新

最后更新发布 (估计)

2011年6月16日

上次提交的符合 QC 标准的更新

2011年6月15日

最后验证

2011年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅