Fast Track Diagnosis of Skin Tumours by Four Different Advanced Imaging Technologies - a Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- diagnostic accuracy of the four methods imaging methods compared to histopathology of skin tumours.
研究概览
简要总结
Aim of study:
To collect data for a new image-guided diagnostic algoritm, enabling the investigators to differentiate more precisely between benign and malignant pigmented tumours at the bedside. This study will include 60 patients with four different pigmented tumours: seborrheic keratosis (n=15), dermal nevi (n=15), pigmented basal cell carcinomas (n=15), and malignant melanomas (n=15), these four types of tumours are depicted in Fig.1, and all lesions will be scanned by four imaging technologies, recruiting patients from Sept 2019 to May 2020. In vivo reflectance confocal microscopy (CM) will be used to diagnose pigmented tumours at a cellular level and provide micromorphological information5;6. Flourescent CM will be applied to enhance contrast in surrounding tissue/tumours. Optical coherence tomography (OCT), doppler high-frequency ultrasound (HIFU) and photoacustic imaging (also termed MSOT, multispectral optoacustic tomography) will be used to measure tumour thickness, to delineate tumours and analyze blood flow in blood vessels. Potential diagnostic features from each lesion type will be tested. Diagnostic accuracy will be statistically evaluated by comparison to gold standard histopathology
详细描述
Study design The prospective non-blinded clinical study will include with seborrheic keratosis (n=15), dermal nevi (n=15), pigmented or dark basal cell carcinomas (n=15), and malignant melanomas (n=15) referred to or diagnosed at Dept. of Dermatology, Bispebjerg Hospital. All tumours are histologically verified by skin biopsy. To explore clinical feasibility and diagnostic accuracy of four different skin imaging technologies all patients will be scanned by an experienced examiner in one 2-hour session. If patients demonstrate more than one skin tumour within the same anatomical location, all lesions will be included and scanned. Lesions in other anatomical areas of the same patient will not be included. The total extra time spend in the department to participate in this study will be approximately 2-3 hours for each patient. Only one visit is required to participate. The skin tumors in patients enrolled will subsequently be treated according to hospital and national guidelines.
Background: A bedside examination of a skin tumours using advanced imaging technology is considered a valuable future tool for Dermatologists. The investigators vision is to provide image guided skin cancer therapy to all patients with skin tumours. This study compares clinical feasibility and diagnostic accuracy of four different imaging technologies applied in a fast-track bedside analysis of various skin tumours; four different types, 2 benign and 2 malignant types.
It is also hypothesized that:
- Due to higher resolution UHR-OCT may have higher diagnostic accuracy than C-OCT.
- Doppler HIFU and optoacustic imaging diagnosis may be more accurate in skin tumours thicker than 1-2 mm compared to diagnosis based on OCT imaging.
- The cellular resolution of RCM and the detailed blood flow information acquired from photoacustic imaging may supplement clinical decision making and increase diagnostic accuracy compared to only OCT or only HIFU.
Study objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- 是
入选标准
- •60 Patients with histologically verified: seborrheic keratosis 15 in total, dermal nevi 15 in total, pigmented BCC in total, and malignant melanomas 15 in total on areas of the body where scanning is feasible with all five systems
- •Patients with skin tumours clinically suspicious of one of the four lesions mentioned in (1), that are not yet biopsied, if the patient is willing to undergo a skin biopsy from the suspicious lesion
- •> 18 years of age at baseline
- •Legally competent, able to give verbal and written consent
- •Communicate in Danish verbally as well as in writing
- •Subject in good general health, is willing to participate and able to give informed consent and can comply with protocol requirements.
排除标准
- •Individuals with other skin diseases in the skin area of interest
- •Individuals who´s skin tumour is not accessible for imaging e.g. inside the ear, inside nostrils, on eyelids
- •Subjects who will not undergo a skin biopsy after imaging of the suspicious tumour clinically diagnosed as BCC
- •Women of child-bearing potential not using a contraceptive agent at the time of inclusion
结局指标
主要结局
diagnostic accuracy of the four methods imaging methods compared to histopathology of skin tumours.
时间窗: 6-12 months
Sensitivity is expressed in percentage and defines the proportion of true positive subjects with the disease in a total group of subjects with the disease (TP/TP+FN). Sensitivity is defined as the probability of getting a positive test result in subjects with the disease (T+\|B+). Specificity is a measure of diagnostic test´s accuracy, complementary to sensitivity. It is defined as a proportion of subjects without the disease with negative test result in total of subjects without disease (TN/TN+FP). Sensitivity and specificity are reported in percent
次要结局
- tumour thickness(6-12 months)
- blood flow in skin tumours(6-12 months)
- survival rates(12 months)
- To report patient satisfaction of scanning procedures(6-12 months)
- To report potential decreased time delay from first visit to efficient skin cancer treatment(12 months)
- To record treatment types and number of therapeutic sessions (e.g. operations)(12 months)
研究者
Mette Mogensen
MD, PhD, Ass. Prof., Chief Consultant
University Hospital Bispebjerg and Frederiksberg