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临床试验/NCT06473766
NCT06473766招募中不适用

Ultrasound RF Data for Discriminating Between Benign and Malignant Ovarian Masses With Solid Ultrasound Morphology, a Feasibility Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
number of examinations readable

研究概览

简要总结

Ultrasound imaging provides useful information for the characterization of ovarian masses as benign or malignant. The most accurate mathematical model to categorize ovarian masses is the IOTA ADNEX model.This model estimates the risk of malignancy and performs similarly to subjective assessment by an experienced ultrasound examiner for discriminating between benign and malignant adnexal masses. The ability of IOTA ADNEX to discriminate between benign and malignant masses is very good (area under the receiver operator characteristic curve 0.937 (95% CI: 0.915-0.954). The ADNEX model maintains its accuracy even in the hands of operators with different experience and training.

According to IOTA terminology, 13% of ovarian masses detected on ultrasound examination are classified as solid. Solid ovarian masses have a risk of malignancy of 60%-75%2 and the discrimination between benign and malignant in this morphological category is challenging. Additionally, it has been estimated that 30% (25/84; 95% CI 18 to 44%) of solid malignant ovarian masses are metastases from non-ovarian tumors. The discrimination between primary ovarian cancer and metastatic tumors in the ovary is also clinically important for planning adequate therapeutic procedures. It is worth exploring the predictive performance of the diagnostic tools in identifying ovarian masses with ultrasound solid morphology.

Preliminary data (unpublished) on radiomics analysis and ovarian masses provided that benign and malignant ovarian masses with solid morphology have different radiomics features in a monocentric retrospective study. However, no statistically significant differences have been observed between primary ovarian cancer and metastases to the ovary.

A new technology is emerging in engineering ultrasound field: the analysis of ultrasound summed RF data- raw data generated by the interface of ultrasound beams with human tissues. To date, raw data are not utilized for conventional imaging and their eventual role in clinical practice is unknown. Indeed, summed RF data could better correlate with biological parameters then parameters identifiable in B-mode images. Summed RF data could also improve radiomic analysis.

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
Female
接受健康志愿者

入选标准

  • Patients with a preoperative ultrasound diagnosis of a solid ovarian mass (solid according to IOTA terminology, i.e. 80% of the tumor consists of solid tissue).
  • Patients who will undergo surgery within 120 days after the ultrasound examination.
  • Patients at least 18 years old.
  • Informed consent signed.

排除标准

  • Patients under 18 years of age.
  • Patient refusal

结局指标

主要结局

number of examinations readable

时间窗: At time of ultrasound examination

Feasibility measured as number of examinations readable, (i.e. number of patients with successful process with diagnosed solid ovarian masses, and acquisition of readable RF data)

次要结局

未报告次要终点

研究者

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

Testa Antonia Carla

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (2)

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