Clinical trial · Interventional
iToBoS: Clinical Data Acquisition Study
iToBoS: Intelligent Total Body Scanner for Early Detection of Melanoma - Clinical Data Acquisition Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The intelligent total body scanner (iToBoS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single participant arm
- description
- 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).
- interventionNames
- Device: The intelligent total body scanner (iToBoS)
Primary outcomes (1)
- measure
- iToBoS image quality assessment
- timeFrame
- Baseline (Month 0)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 years or older 2. Able to provide written informed consent 3. Willing to attend 3 clinical visits over a 12-month period 4. Willing to provide a genetic sample (optional) 5. Willing to follow the clinical procedures (e.g. no physical restrictions from imaging process) 6. Have a BMI between 18.5 to 40 kg/m2 7. Have a height between 140 - 190 cm 8. Have a thorax height (participant lying face up) of 20 - 45 cm 9. Have an elbow to elbow width (breadth) of 40-50cm Exclusion Criteria: 1. Have a pacemaker 2. Are pregnant, or planning to become pregnant 3. 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.
References
Publications (0)
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