iToBoS: Clinical Data Acquisition Study

NCT05075356 | Unknown DMC

• 1 other identifier: D1.4
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Melanoma

Keywords

Total Body Imaging; Diagnostic; Artificial Intelligence; Skin Examination

Outcome Measures

Primary Outcomes (1)

• iToBoS image quality assessment

  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.

  Baseline (Month 0)

Secondary Outcomes (4)

• Creation of labelled datasets for AI training

  Baseline (Month 0)

• Refinement of a holistic risk score algorithm

  Month 12

• Safety Assessment

  At completion of study (Month 12)

• Detecting change in lesions imaged (from baseline to month 12)

  At completion of the study (Month 12)

Study Arms (1)

Single participant arm

EXPERIMENTAL

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).

Device: The intelligent total body scanner (iToBoS)

Interventions

The intelligent total body scanner (iToBoS) DEVICE

The intelligent total body scanner (iToBoS) device will be an AI diagnostic platform for early detection for melanoma, which includes a novel total-body high-resolution scanner and a Computer Aided Diagnostics (CAD) tool. The prototype iToBoS imaging device used in this study, will not have the integrated CAD system. The device consists of a horizontal bed on which the participant would lie on. The bed will slide under a series of 5 arc shaped rails that have a total of 15 vision units mounted on rails (3 vision units per arc). The vision units incorporate high-resolution cameras and LED lighting system. When imaging is initiated by an operator, the vision units systematically move along the arch rails taking numerous images capturing majority of the skin surface. The imaging process will take approx. 10 minutes. Purpose built software will be used to stitch images together to create a body avatar on which skin lesions can be viewed and monitored with.

Also known as: iToBoS

Single participant arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Queensland: lead
• Universitat de Girona: collaborator
• Fundacion Clinic per a la Recerca Biomédica: collaborator
• University of Trieste: collaborator
• Trilateral Research Limited: collaborator
• Robert Bosch Espana Fabrica: collaborator
• IBM Israel - Science and Technology Ltd: collaborator

Related Links

• The European Union's results page for the Horizons 2020 grant funding this project

MeSH Terms

Conditions

Melanoma; Disease

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Soyer, MD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

• Rafael Garcia, PhD

  Universitat de Girona

  STUDY DIRECTOR

Central Study Contacts

Clare A Primiero, BSc

CONTACT

+61 7 344 37496; c.bover@uq.edu.au

Katie Lee, BSci

CONTACT

+61 7 344 37482; k.lee5@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will follow the same protocol (single arm).

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 12, 2021
• Study Start: September 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: May 14, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: These challenges will run 2025-2026
• Access Criteria: The datasets will be shared in international conferences, for example MICCAI (Medical Image Computing and Computer Assisted Intervention) or similar, where the challenge and corresponding workshop will run. The details are not finalised at this stage.