Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients (IMAGE)

This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.

It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma; Skin Cancer; Anxiety and Fear
• Intervention / Treatment: Device: 2D or 3D Melanoma Surveillance Photography

Detailed Description

The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts.

The secondary aims are to:

1. Evaluate whether MSP:

   1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
   2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
   3. Reduces costs to patients and health care system
2. Evaluate the safety and acceptability of MSP
3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2).

Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to:

1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
3. Improved quality of life; and
4. Favourable health economic outcomes.

• Study Type: Interventional
• Enrollment (Actual): 670
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Newcastle, New South Wales, Australia, 2290
      • Newcastle Skin Check
    • Sydney, New South Wales, Australia, 2145
      • Dermatology Clinical Trials Unit, Westmead Hospital
    • Wollstonecraft, New South Wales, Australia, 2065
      • Melanoma Institute Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Diamantina Institute, University of Queensland
    • Cairns, Queensland, Australia, 4870
      • FNQH Cairns Skin Cancer Centre
    • Townsville, Queensland, Australia, 4812
      • Skin Repair Skin Cancer Clinic, Townsville
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Bendigo Cancer Centre Research Unit, Bendigo Health
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute
    • Cowes, Victoria, Australia, 3922
      • Phillip Island Health Hub, Bass Coast Health
    • Melbourne, Victoria, Australia, 3004
      • Victorian Melanoma Service, Alfred Health
    • Wonthaggi, Victoria, Australia, 3995
      • Wonthaggi Hospital, Bass Coast Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

Patients may be included in the study if they meet ALL of the following criteria:

1. Aged 18 years or older at date of diagnosis
2. Within 24 months (2 years) of the date of diagnosis when attending Screening & Baseline Visit: where date of diagnosis refers to the date on the pathology report that provides histological confirmation of primary cutaneous melanoma (insitu or invasive)
3. Able to provide informed consent, complete questionnaires, and attend trial site for MSP*
4. Appropriate for TBP referral
5. High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix IV)*
6. Multiple naevi, as "some" or "many" naevi on pictogram below at Screening & Baseline visit.
7. Not previously under active surveillance (at least yearly) with TBP for melanoma surveillance (see inclusion criteria 9)
8. Living in Australia and not planning to move overseas within the next 3 years

9. Participants that meet all eligibility criteria but have previously been under active surveillance with TBP for at least the previous 2 years meet exclusion critierion 1, in which case they are ineligible for the main study and eligible for sub-study 1 only.

   Active surveillance with TBP refers to TBP images having been taken AND used for melanoma surveillance. As such, if a patient had TBP but these images were not used for melanoma surveillance (i.e. not used by clinicians to monitor a patient's skin), then surveillance is not considered active and the patient would still be eligible for the main study (as well as sub-study 1).

10. Patients need to have had at least annual surveillance over the past 2 years (at least) to be eligible for sub-study 1 (note that this refers to annual skin surveillance not annual TBP images being taken) (i.e. do not meet inclusion criteria 7 are eligible for sub-study 1)

Exclusion criteria

Patients will be excluded from the study for ANY of the following reasons:

1. Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma
2. Stage IV metastatic melanoma
3. Ocular melanoma, mucosal melanoma
4. Participation in another clinical trial or study involving MSP

Note:

A past history of other cancers is not an exclusion criteria.

*These eligibility criteria cannot be assessed by the cancer registry. These criteria will be assessed by the study team and/or referring doctor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of Care plus Melanoma Surveillance Photography; Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.	Device: 2D or 3D Melanoma Surveillance Photography; Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.
No Intervention: Standard of Care; Clinical surveillance standard of care without Melanoma Surveillance Photography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of melanoma surveillance	The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of MSP	Standard health economic cost-effectiveness measures.	24 months
Diagnostic performance for melanoma	Agreement and reliability indices.	24 months
Diagnostic performance for keratinocyte lesions	Agreement and reliability indices.	24 months
Health-Related Quality of life	Assessment of Quality of Life (AQOL-8D) questionnaire for calculation of quality-adjusted life years (QALYs). Minimum score per each of 8 questions is 1; maximum score is 5, where higher score represents worse outcomes. Scores may be aggregated to provide an overall index of the health state utility per participant, where higher scores indicate worse quality of life outcomes.	24 months
Patient anxiety	European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Fear of Cancer Recurrence - short form (FCR4) and a purpose-designed patient acceptability scale will be utilised to synthesise a single endpoint measure for patient anxiety. Value range is 0 to 100, where higher values represent greater anxiety (worse outcomes).	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
IMAGE Sub-study 1: PRE-TRIAL EXCISION RATES	To estimate the benefit of MSP in high risk patients prior to a melanoma diagnosis, amongst participants who would have been classified as 'high risk' at the time of their primary melanoma, this sub-study will compare: i) Breslow thickness of the primary melanoma at entry into this trial, and ii) Biopsy rates prior to diagnosis	5 year (retrospective)
IMAGE Sub-study 2: TELEDIAGNOSIS VALIDATION	Approximately 100 paired sets of 3D surveillance and digital dermoscopy images (baseline and follow-up) taken from patients in the intervention arm, will be sent to 10 participating study doctors (both GPs and dermatologists; all 100 pairs sent to all 10 doctors) for teledermatology assessment. The study doctors will assess the images with respect to whether they have a melonama present or not. Images will be selected randomly from amongst patients accrued to the main study for this telediagnosis validation study. Approximately 30% of these will include an image of a melanoma confirmed by histopathology (gold standard) during the trial. This substudy will not affect patient care but will assess diagnostic performance (sensitivity and specificity) in the teledermatology setting compared to the en-face clinical setting in order to validate the use of telediagnosis in routine care.	Validity analysis undertaken at a single time point based on data accrued over 24 month study period.

Collaborators and Investigators

• Sponsor: Melanoma and Skin Cancer Trials Limited
• Collaborators: Monash University; University of Sydney; The University of Queensland

Publications and helpful links

Helpful Links

• Detailed information on the IMAGE trial

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Biopsy; Health economics; Dermatology; Health-related Quality of Life; Excision; Teledermatology; 2D Total Body Imaging; 3D Total Body Imaging; Melanoma Surveillance Photography; Health system utilisation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 02.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No