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临床试验/NCT07803406
NCT07803406招募中不适用

Multimodal Imaging of Basal Cell Carcinoma: A Usability Study

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Time consumption per imaging modality

研究概览

简要总结

The goal of this observational study is to evaluate the time efficiency and practical usability of three non-invasive skin imaging tools in adults (18 years and older) with basal cell carcinoma (BCC), the most common type of skin cancer. The main questions it aims to answer are:

How long does it take to perform each scan (optical coherence tomography, line-field confocal optical coherence tomography, and high-frequency ultrasound)? How comfortable is each scan for participants? How well do the imaging tools work across different areas of the body?

Participants will undergo one study visit of approximately 40 minutes, during which three non-invasive skin scans are performed on the skin lesion. Each scan uses a different imaging tool. Participants will also complete a short questionnaire about their experience. No biopsies or other invasive procedures are performed as part of the study.

详细描述

Background:

Basal cell carcinoma (BCC) is the most common type of skin cancer, accounting for approximately 80% of all keratinocyte carcinomas. Although BCC rarely spreads to other parts of the body, it can cause considerable damage to surrounding tissue if left untreated, and both its diagnosis and management place a substantial economic burden on healthcare systems.

The current gold standard for diagnosing BCC is a biopsy with histopathological examination, in which a small sample of skin is removed and examined under a microscope by a pathologist. While highly accurate, this procedure is invasive, causes discomfort, leaves a scar, and requires laboratory processing time before a diagnosis can be confirmed. In clinical practice, dermoscopy (a non-invasive handheld magnification tool) is widely used as a first-line technique to examine surface and near-surface skin structures and guide clinical decision-making. However, dermoscopy does not provide information about tumor depth, subcutaneous invasion, or detailed tissue architecture at the cellular level.

Over the past decade, new non-invasive imaging technologies have emerged that allow detailed visualization of skin lesions at varying depths and resolutions, without the need for tissue removal. These include optical coherence tomography (OCT), line-field confocal optical coherence tomography (LC-OCT), and high-frequency ultrasound (HFUS). Each of these modalities offers complementary information about the skin and underlying tissue. In recent years, artificial intelligence (AI) software modules have been integrated into these imaging systems to assist clinicians in interpreting images and detecting BCC-specific features automatically in real time.

Despite growing evidence that these imaging modalities can detect and characterize BCC with high accuracy, their clinical usability has not been systematically evaluated in a prospective, real-world clinical setting comparing all three modalities head-to-head. This knowledge gap highlights the need for dedicated usability studies to generate essential real-world data that can inform clinical implementation.

研究设计

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

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

  • Age 18 years or older Presence of a histologically confirmed or clinically suspected basal cell carcinoma lesion scheduled for standard clinical management Ability to provide written informed consent

排除标准

  • Inability to provide informed consent

研究组 & 干预措施

BCC Participants

Adults aged 18 years or older with histologically confirmed or clinically suspected basal cell carcinoma scheduled for standard clinical management at the Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark. Each participant undergoes a single study visit comprising sequential non-invasive imaging with three AI-assisted modalities: optical coherence tomography (OCT), line-field confocal optical coherence tomography (LC-OCT), and high-frequency ultrasound (HFUS). No interventions are performed. All imaging is adjunct to standard care.

干预措施: Non-invasive multimodal skin imaging (Device)

结局指标

主要结局

Time consumption per imaging modality

时间窗: Single study visit, approximately 40 minutes per lesion

Time consumption measured in minutes per patient for each modality (OCT, LC-OCT, and HFUS) and in total, recorded from the start of device set-up to the completion of image acquisition and documentation.

次要结局

  • Patient-reported discomfort during imaging(Assessed immediately after completion of all imaging procedures at the single study visit.)
  • Practical feasibility of scanning across anatomical regions(Assessed immediately after completion of all imaging procedures at the single study visit.)
  • Image quality across anatomical regions(Assessed immediately after completion of all imaging procedures at the single study visit.)

研究者

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

Merete Haedersdal

Professor, Medical Doctor

Bispebjerg Hospital

研究点 (1)

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