Ruolo Della PET/TC Nella Valutazione di Patologia Tiroidea in un Centro di Medicina Nucleare ad Alto Volume Diagnostico
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- diagnostic performance
研究概览
简要总结
The thyroid gland may have a diffuse or focal uptake of numerous PET/CT radiopharmaceuticals and this may be correlated with underlying benign and malignant thyroid/parathyroid pathologies.
It is not clear at present if the uptake of the radiopharmaceutical alone is associated with a potential malignancy of the disease.
The aim of the study is to collect evidence and consolidate the diagnostic power of PET/CT, to identify any predictive parameters that can determine whether PET positivity/negativity can in the future avoid unnecessary tests such as needle aspiration.
详细描述
The primary objective of the study is to measure the diagnostic performance of PET/CT (with tracers used in our Center for Nuclear Medicine by normal clinical practice), in the identification of malignancy of thyroid or parathyroid findings, compared to cytological/histological examination in patients with known thyroid and/or parathyroid disease or in patients with incidental findings. The secondary objective is to find functional parameters and predictive imaging of malignancy/benign and risk class of the lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •For the retrospective part:
- •Patients aged >18 years,
- •Findings of hypercaptant of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice,
- •Patients with cytological examination derived from needle aspiration performed no more than 12 months time apart from PET/CT.
- •Obtaining informed consent
- •For the prospective part:
- •Patients aged >18 years,
- •Finding hypercaptant findings of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice.
- •Patients scheduled for agesult to be no more than 12 months.
- •Obtaining informed consent
排除标准
- 未提供
结局指标
主要结局
diagnostic performance
时间窗: 5 years and 6 months
Sensitivity, specificity, AUC, detection rate, accuracy, positive and negative predictive value compared to the reference standard.
次要结局
未报告次要终点