MoleGazer Development Feasibility Study

NCT05015816 | Active Not Recruiting

• 1 other identifier: 14872
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

Melanoma (skin cancer) frequently develops from existing moles on the skin. Current practice relies on expert dermatologists being able to successfully identify new/changing moles in individuals with multiple moles. Total body photography (TBP-high-quality images of the entire skin) can track and monitor moles over time to detect melanoma. However, TBP is currently used as a visual guide when diagnosing melanoma, requiring visual inspection of each mole sequentially. This process is challenging, time-consuming and inefficient. Artificial intelligence (AI) is ideally suited to automate this process. Comparing baseline TBP images to newly acquired photographs, AI techniques can be used to accurately identify and highlight changing moles, and potentially distinguish harmless moles from cancerous changes. Astrophysicists face a similar problem when they map the night sky to detect new events, such as exploding stars. Using AI, based on two or more images, astrophysicists detect new events and accurately predict how they will appear subsequently. This project, called MoleGazer, is a collaboration with astrophysicists aiming to apply AI methods that are currently used for astronomical sky surveys, to TBP images. The MoleGazer algorithm, developed at Oxford University Hospitals NHS Foundation Trust, will automatically identify the appearance of new moles and characterise changes in existing ones, when new TBP images are taken. To optimise this MoleGazer algorithm TBP images will be taken at multiple time-points, as there are no existing datasets of TBP images that are publicly available. The investigators invite a) high-risk patients attending skin cancer screening clinics to attend sequential three-monthly TBP imaging and clinical assessment and b) any patient who undergoes TBP as standard care to share images so that the investigators can develop the MoleGazer algorithm. The ultimate goal is for the MoleGazer algorithm to 'map moles' over a patient's lifetime to detect changes, with the eventual aim to detect melanoma as early as possible.

Conditions

Melanoma (Skin); Moles Multiple Benign

Outcome Measures

Primary Outcomes (2)

• Functional algorithm to map naevi sequentially

  The primary objective of this study is to develop the MoleGazer algorithm

  3 years

• Number of TBP images in database

  To develop an anonymised database of digital total body photography images

  3 years

Secondary Outcomes (8)

• Proportion of high quality images amenable to evaluation

  3 years

• The proportion of participants who complete a dataset of three-monthly imaging (Group A)

  2 years

• The proportion of TBP images that can be registered and consistently deformed using existing astronomical software adapted for this purpose

  1 year

• The number of naevi detected by our algorithm from TBP images compared to those determined by an experienced dermatologist

  1 year

• The distribution of naevi detected by our algorithm from TBP images compared to those determined by an experienced dermatologist

  1 year

Study Arms (2)

Group A: Time series

EXPERIMENTAL

Individuals at high risk of developing melanoma will be invited to attend for sequential TBP imaging, full body skin examination by a Dermatologist and completion of a case report form (CRF) every three months for two years. At the end of the study participants will also be invited to complete a feasibility questionnaire

Diagnostic Test: Total body photography

Group B: Baseline cohort

NO INTERVENTION

All patients who undergo standard care and are selected for total body photography (TBP) imaging will be invited to consent to this group. Any individuals who have had previous TBP imaging will also be eligible to enter Group B of this study. A baseline CRF will be completed and a participant feasibility questionnaire. There will be no additional images taken for the purposes of the study and no additional clinic visits in relation to this part of the study. However, individuals who consent to Group B will also agree to share any future TBP images taken in the department over the next two years so that any sequential images can also be included in the analysis

Interventions

Total body photography DIAGNOSTIC_TEST

3 monthly TBP imaging

Group A: Time series

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Male or Female, aged 18-80 years old
• In addition for Group A:
• Willing to attend for additional study visits and total body photography imaging
• High-risk melanoma patients including:
• Dysplastic / atypical naevus syndrome (\> 60 moles +/- personal history of melanoma)
• Family history of melanoma
• Past history of at least two primary melanoma or melanoma-in situ
• At least 3 first-degree or second-degree relatives with prior melanoma
• CDKN2A or CDK4 germline mutation
• Individuals with multiple naevi (\>25) who are immunosuppressed from any cause (e.g. organ transplant recipients, chronic lymphocytic leukaemia, etc.)
• In addition for Group B:
• ● Has previously had total body photography imaging OR will have total body photography as part of standard care

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Patient unable to consent
• Patient with active malignancy affecting any organ and receiving any cancer-specific treatment
• Poor mobility / unable to hold recommended positions for standard TBP imaging
• Individuals who do not understand English
• In addition for Group A:
• ● Unable to attend for three-monthly study visits

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Southampton: collaborator

Study Sites (1)

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

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

Study Officials

• Rubeta N Matin, PhD FRCP

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: August 20, 2021
• Study Start: September 13, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)