iToBoS: Intelligent Total Body Scanner for Early Detection of Melanoma - Clinical Data Acquisition Study
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- iToBoS image quality assessment
研究概览
简要总结
The (overarching) iToBoS Project involves 18 research partners spanning the European Union (including UK and Israel), and 1 Australian partner. The overall aim is to develop an AI assisted diagnostic platform for the early detection of melanoma.
The Clinical Data Acquisition Study (this study) will recruit 600 participants across 3 international sites (Brisbane, Italy, and Spain). The primary objective is to compare the quality and resolution of conventional dermoscopic images of skin lesions with the full-body images captured by the iToBoS imaging system. Secondary objectives are to collect imaging, clinical and genetic data across the three sites, to create labelled datasets for use in training the iToBoS AI component. Also, to refine and develop a holistic melanoma risk score method to be used for the iToBoS system. Lastly, to assess safety of the iToBoS system.
At study site we will aim to recruit 200 participants stratified by risk (of melanoma) categories (low/normal, high, and ultra-high). Participants will be required to attend 3 study visits (months 0, 6 and 12), for total body imaging with the iToBoS system, and dermoscopic images of individual moles. Genetic research and clinical testing are an optional part of the study.
详细描述
Synopsis
The overall aim of the wider iToBoS projectis to build a new imaging and diagnostic tool for the early detection of melanoma, incorporating all the available information of the participant. This holistic assessment tool should incorporate the specific characteristics of every participant in order to enable a personalised, early detection of melanoma.
The aim of this prospective clinical study is to collect imaging, phenotypic, clinical and genetic data necessary to develop the iToBoS System as an integrative diagnostic platform for melanoma detection. This will be completed by recruiting 600 participants across three study sites (200 each at Barcelona Spain, Trieste Italy, and Brisbane Australia), to be imaged using the iToBoS system and conventional dermoscopy. The data acquired in this study will be used to achieve three key objectives;
- To evaluate the resolution and usability (for diagnosis) of the iToBoS images compared with traditional dermoscopic images. (Primary Objective)
- To collect an image database for training the AI component of the iToBos System.
- To refine previous melanoma risk assessments to develop a holistic melanoma risk score.
A subsequent clinical study (separate protocol), will be conducted to validate the developments from this study using a refined iToBoS System and AI Cognitive Assist Tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Aged 18 years or older
- •Able to provide written informed consent
- •Willing to attend 3 clinical visits over a 12-month period
- •Willing to provide a genetic sample (optional)
- •Willing to follow the clinical procedures (e.g. no physical restrictions from imaging process)
- •Have a BMI between 18.5 to 40 kg/m2
- •Have a height between 140 - 190 cm
- •Have a thorax height (participant lying face up) of 20 - 45 cm
- •Have an elbow to elbow width (breadth) of 40-50cm
排除标准
- •Have a pacemaker
- •Are pregnant, or planning to become pregnant
- •Any condition in which the investigator's opinion may adversely affect the participant's ability to complete the study, or its measures, or which may pose significant risk to the participant.
研究组 & 干预措施
Single participant arm
The iToBoS intervention is a total body imaging device, to image the total skin surface in order to detect and monitor for signs of skin cancer.
The imaging process involves laying down on a bed that has a framework of cameras arched over it. The imaging process takes less then 10 minutes, and requires the participant to lay in two different positions (face-up and face-down).
The study visit also includes individual dermoscopic images taken of certain moles on the skin. This is done in combination with a clinical skin examination. Participants are given the option of providing a saliva sample for genetic research. Participants are then asked to complete a series of questionnaires.
There a three visits in total (month 0, 6 and 12), in which these procedures are repeated (except for saliva sample).
干预措施: The intelligent total body scanner (iToBoS) (Device)
结局指标
主要结局
iToBoS image quality assessment
时间窗: Baseline (Month 0)
The primary outcome measure of this study is the assessment of image quality of total-body photography taken with the iToBoS system. A clinical and quantitative comparison of conventional dermoscopy images of individual lesions with iToBoS images will be systematically assessed by a panel of dermatologically trained clinicians and research assistants. The panel will be asked to independently assess the iToBoS image and dermoscopic images as acceptable or not acceptable. Three panel members will assess each image, with consensus being considered with agreement of 2 or more. The order of the images presented to each panel member will be randomised.
次要结局
- Creation of labelled datasets for AI training(Baseline (Month 0))
- Refinement of a holistic risk score algorithm(Month 12)
- Detecting change in lesions imaged (from baseline to month 12)(At completion of the study (Month 12))
- Safety Assessment(At completion of study (Month 12))