iToBoS: Clinical Data Acquisition Study

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

Interventions

DEVICE

The intelligent total body scanner (iToBoS)

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.

Sponsors & Collaborators

• Universitat de Girona

  collaborator OTHER

• Fundacion Clinic per a la Recerca Biomédica

  collaborator OTHER

• University of Trieste

  collaborator OTHER

• Trilateral Research Limited

  collaborator UNKNOWN

• Robert Bosch Espana Fabrica

  collaborator UNKNOWN

• IBM Israel - Science and Technology Ltd

  collaborator UNKNOWN

• The University of Queensland

  lead OTHER

Principal Investigators

• Peter Soyer, MD · The University of Queensland

• Rafael Garcia, PhD · Universitat de Girona

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2025-03-30

Completion

2025-03-30