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临床试验/NCT04730726
NCT04730726Unknown不适用

In Vivo Multispectral Optoacoustic Imaging of Thyroid Nodules

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
MSOT signals of endogenous biomarkers

研究概览

简要总结

Thyroid nodules are common in clinical practice. Head and neck ultrasound is recommended as a routine examination for all patients with thyroid lesions. The Thyroid Imaging Reporting And Documentation System (TIRADS) criteria helps to estimate the risk of malignancy based on ultrasound patterns and nodule sizes guiding the performance of fine-needle-aspiration (FNA). Approximately 20% of FNA results cannot be specified whether being benign or malig-nant tissue. A definitive diagnosis can only be made from histopathology after diagnostic (hemi)thyroidectomy. However, (hemi)thyroidectomy has disadvantages as it leads to over-treatment and has a risk of postoperative morbidity (e.g. hypothyroidism and laryngeal nerve injury). Furthermore, (hemi)thyroidectomy is known to be associated with poor quality of life. Clearly, there is an unmet need for additional diagnostic tools in order to identify malignant thyroid nodules and thereby support the decision making for treatment of the thyroid.

Multispectral optoacoustic tomography (MSOT) is an innovative, non-invasive imaging method currently available in the UMCG that enables visualization of endogenous chromophores and exogenous contrast agents using the generation of ultrasound waves due to light absorption by using high frequency pulsed laser light. Recently, this system has been used by other groups for non-invasive determination of thyroid nodules. Results show that multispectral optoacoustic imaging of thyroid nodules may distinguish benign from malignant nodules. However, most certainly, a larger cohort is necessary to confirm this finding.

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

入选标准

  • Patients with thyroid nodules who underwent or will undergo an ultrasonography (with TIRADS score) with FNA if indicated and will be scheduled for a (hemi)thyroidectomy if indicated;
  • Age ≥ 18 years;
  • Written informed consent.

排除标准

  • Medical or psychiatric conditions that compromise the patients' ability to give informed consent;
  • Previous surgery in head and neck area
  • Previous radiotherapy in head and neck area

结局指标

主要结局

MSOT signals of endogenous biomarkers

时间窗: 2 years

HbO2, HbR, HbT, sO2, fat, water and collagen

次要结局

  • Potential correlation ultrasound(2 years)
  • Potential correlation FNA(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Schelto Kruijff, MD PhD

Dr.

University Medical Center Groningen

研究点 (2)

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