Role of of F-18-fluoro-deoxy-glucose (FDG) PET/CT in Thyroid Cancer Patients With Negative I-131whole Body Scan and Elevated Thyroglobulin Level or Positive Anti Thyroglobulin Antibodies
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 主要终点
- Recurrence and metastasis
研究概览
简要总结
Background and Rational
(Introduction)
Differentiated thyroid carcinoma (DTC) have favorable prognosis. Overall 10-year survival is 93% for papillary carcinoma, and 85% for follicular carcinoma(1). After total thyroidectomy followed by radioiodine remnant ablation, DTC patients are screened for recurrence by measuring the levels of both Tg and TgAb and I-131 whole body scan (WBS) in the follow-up (2) It is reported that elevated TgAb may indicate the recurrent and/or metastatic disease and can be used as an alternative of the tumor marker for DTC . The I-131 WBS has high specificity to detect recurrence (50 to 60% in papillary thyroid carcinoma and 64 to 67% in follicular thyroid carcinoma) (3,4). The I-131WBS showed negative finding in 10 to 15% of patients with detectable serum Tg levels(5). Two factors may account for discrepancy between serum Tg and I-131 WBS . First, the tumor size might be too small to be detected by WBS. Second, the tumor cell may lose the ability to trap radioiodine while still able to secret Tg(6,7). It becomes necessary to investigate with other modalities to identify possible residual disease to initiate the appropriate treatment. (8)
Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (18F-FDG PET/CT) has emerged as a powerful imaging tool for the detection of various cancers. (9)
The combined acquisition of PET and CT has synergistic advantages over PET or CT alone and minimizes their individual limitations. (10)
It is a valuable tool for staging and re staging of some tumors and has an important role in the detection of recurrence in asymptomatic patients with rising tumor marker levels and patients with negative or equivocal findings on conventional imaging techniques.(11)
Aim of the study
The aim of this study was to evaluate the diagnostic accuracy of (PET/CT) in patients with suspected thyroid cancer recurrence or metastasis , with differentiated thyroid cancer (DTC) patients who show elevated serum thyroglobulin (Tg) or antithyroglobulin antibody (TgAb) level with negative radioiodine whole body scan (I-WBS).
详细描述
Design and Methodology
Study design:-
It's a prospective study for the group of patients who will do F-18FDG PET/CT scan after negative whole body scan with elevated serum thyroglobulin Antibody or Thyroglobulin levels.
Pre-study investigations:-
- All patients at this study should have histopathological evidence of DTC
- serum TSH level
- serum TG & antiTG antibodies levels
- radioactiveiodine whole body scan (I-WBS)
- Neck ultrasound
- Blood glucose level
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •· This study will include thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.
- •Patients able to sleep in a fixed position for 20 minutes.
排除标准
- •Patients unable to sit calm without movement during imaging.
- •Severely ill patients.
- •Patients' blood glucose > 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
- •Pregnancy
结局指标
主要结局
Recurrence and metastasis
时间窗: six months
Detection of recurrence or metastasis in patient with negative radioactive iodine scan and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.By progressively increase level of serum Thyroglobulin or thyroglobulin antibodies
次要结局
- Improve survival rate(six months)
研究者
RMFarghali
Principal investigator
Assiut University