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临床试验/NCT06379581
NCT06379581暂停不适用

Photoacoustic Imaging for Three-dimensional Delineation of Skin Tumors

Region Skane2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
Region Skane
入组人数
200
试验地点
2
主要终点
Tumor thickness

研究概览

简要总结

In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth.

详细描述

The study will employ multispectral photoacoustic imaging in the spectral range between 680-970 nm to scan suspected skin tumors both in vivo and ex vivo. The hyperspectral data will then undergo rigorous spectral analysis with the objective to identify the spectral fingerprints associated with healthy tissue and tumor. Thereafter, a classification algorithm will be used to determine whether a pixel in the acquired image more likely identifies with healthy tissue or tumor, which is then repeated for all pixels in the images. As such, a 3D image can be reconstructed in which the tumor is visibly contrasted from healthy tissue. Achieving this goal will facilitate the diagnostic procedures and greatly reduce waiting times, clinical costs and potential patient suffering.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients scheduled to perform surgical excision of lesion(s) suspected to be tumors.

排除标准

  • 未提供

研究组 & 干预措施

Patients with suspected skin tumors

With the help of photoacoustic imaging (PAI), determine the border between healthy tissue and tumor by determining the difference in chromophoric composition by their difference in absorption spectral features.

结局指标

主要结局

Tumor thickness

时间窗: Enrollment is anticipated to last 1 year + final analyse 6 months

Compare the estimated tumor thickness of tumor lesion with the provided thickness from the histopathological investigation.

Tumor size

时间窗: Enrollment is anticipated to last 1 year + final analyse 6 months

Compare the estimated tumor surface size of tumor lesion with the provided thickness from the histopathological investigation.

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (2)

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