MelanomaIMAGENCT04385732
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
A study testing 2D or 3D Melanoma Surveillance Photography in people with Melanoma and Skin Cancer, run by Melanoma and Skin Cancer Trials Limited at 12 sites in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Skin Cancer, Anxiety and Fear
- What is being tested?
- 2D or 3D Melanoma Surveillance Photography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 12 sitesAustralia
- Study dates
- 3 Mar 2021to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be included in the study if they meet ALL of the following criteria:
- Aged 18 years or older at date of diagnosis
- 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)
- Able to provide informed consent, complete questionnaires, and attend trial site for MSP*
- Appropriate for TBP referral
- High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix IV)*
Show all 12Show fewer
- Multiple naevi, as "some" or "many" naevi on pictogram below at Screening \& Baseline visit.
- Not previously under active surveillance (at least yearly) with TBP for melanoma surveillance (see inclusion criteria 9)
- Living in Australia and not planning to move overseas within the next 3 years
- 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).
- 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)
Who cannot join
- Patients will be excluded from the study for ANY of the following reasons:
- Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma
- Stage IV metastatic melanoma
- Ocular melanoma, mucosal melanoma
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Australia12 sites
Bendigo Cancer Centre Research Unit, Bendigo Health
Bendigo, Victoria, 3550
Diamantina Institute, University of Queensland
Brisbane, Queensland, 4102
FNQH Cairns Skin Cancer Centre
Cairns, Queensland, 4870
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Skin Health Institute
Carlton, Victoria, 3053
Phillip Island Health Hub, Bass Coast Health
Cowes, Victoria, 3922
Victorian Melanoma Service, Alfred Health
Melbourne, Victoria, 3004
Newcastle Skin Check
Newcastle, New South Wales, 2290
Dermatology Clinical Trials Unit, Westmead Hospital
Sydney, New South Wales, 2145
Skin Repair Skin Cancer Clinic, Townsville
Townsville, Queensland, 4812
Melanoma Institute Australia
Wollstonecraft, New South Wales, 2065
Wonthaggi Hospital, Bass Coast Health
Wonthaggi, Victoria, 3995
About this study
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.
Read the 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:
- Evaluate whether MSP:
- Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
- Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
- Reduces costs to patients and health care system
- Evaluate the safety and acceptability of MSP
- Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
- 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:
- Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
- Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
- Improved quality of life; and
- Favourable health economic outcomes.
- Conditions
- Melanoma, Skin Cancer, Anxiety and Fear
- Being tested
- 2D or 3D Melanoma Surveillance Photography
- Keywords
- Dermatology, Teledermatology, 2D Total Body Imaging, 3D Total Body Imaging, Melanoma Surveillance Photography, Biopsy, Excision, Health-related Quality of Life, Health system utilisation, Health economics
- Medical subject headings
- Melanoma, Skin Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D or 3D Melanoma Surveillance PhotographyDevice
Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care plus Melanoma Surveillance Photography | Experimental | Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy. Receives: Device: 2D or 3D Melanoma Surveillance Photography |
| Standard of Care | No intervention | Clinical surveillance standard of care without Melanoma Surveillance Photography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
Cost-effectiveness of MSP
Standard health economic cost-effectiveness measures.
Measured: 24 months
Diagnostic performance for melanoma
Agreement and reliability indices.
Measured: 24 months
Diagnostic performance for keratinocyte lesions
Agreement and reliability indices.
Measured: 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.
Measured: 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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start3 Mar 2021
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is an open-label, multi-site, parallel-arm randomised controlled trial. Participants meeting the eligibility criteria will be randomised 1:1 to either standard care or the intervention arm. Randomisation will be 1:1 to either Intervention or Control group stratified by high/ultra-high risk of 2nd primary melanoma, sex, 2D/3D imaging, GP/Dermatologist.
- Masking
- None (open label)
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melanoma and Skin Cancer Trials Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, University of Sydney, The University of Queensland
- Responsible party
- Sponsor
- Investigators
- Victoria Mar, Principal investigator, Monash University and Alfred Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385732
- Sponsor's protocol ID
- 02.19
- Acronym
- IMAGE
- Status last verified
- Nov 2024
- First submitted
- 1 Apr 2020
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan MK, Cust AE, Soyer HP, Janda M, Loewe K, Byars G, Fishburn P, White P, Mahumud RA, Saw RPM, Herschtal A, Fernandez-Penas P, Guitera P, Morton RL, Kelly J, Wolfe R, Mar VJ. Study protocol for a randomised controlled trial to evaluate the use of melanoma surveillance photography to the Improve early detection of MelanomA in ultra-hiGh and high-risk patiEnts (the IMAGE trial). Trials. 2023 Mar 29;24(1):236. doi: 10.1186/s13063-023-07203-5.
PubMed 36991460
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
- ClinicalTrials.gov ID
- NCT04385732
- Acronym / sponsor ID
- IMAGE / 02.19
- Conditions
- Melanoma, Skin Cancer, Anxiety and Fear
- Keywords
- Dermatology, Teledermatology, 2D Total Body Imaging, 3D Total Body Imaging, Melanoma Surveillance Photography, Biopsy, Excision, Health-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Melanoma and Skin Cancer Trials LimitedUniversity, hospital or other
- Collaborators
- Monash University, University of Sydney, The University of Queensland
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Evaluate whether MSP:
- Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives)
- Improves health-related quality of life, patient satisfaction, and reduces patient anxiety
- Reduces costs to patients and health care system
- Evaluate the safety and acceptability of MSP
- Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1)
- 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:
- Reduction in the number of misclassified melanoma malignancies (i.e. false negatives);
- Reduction in the number of misclassified melanocytic and keratinocyte lesions combined;
- Improved quality of life; and
- Favourable health economic outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial is an open-label, multi-site, parallel-arm randomised controlled trial. Participants meeting the eligibility criteria will be randomised 1:1 to either standard care or the intervention arm. Randomisation will be 1:1 to either Intervention or Control group stratified by high/ultra-high risk of 2nd primary melanoma, sex, 2D/3D imaging, GP/Dermatologist.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care plus Melanoma Surveillance Photography | Experimental | Device: 2D or 3D Melanoma Surveillance PhotographyClinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy. |
| Standard of Care | No intervention | –Clinical surveillance standard of care without Melanoma Surveillance Photography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18 years or older at date of diagnosis
- 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)
- Able to provide informed consent, complete questionnaires, and attend trial site for MSP*
- Appropriate for TBP referral
- High/very high risk of subsequent primary melanoma (see risk assessment tool, Appendix IV)*
Key exclusion criteria (8 listed)
- Previously under active surveillance with TBP (active surveillance referring to TBP images being used for melanoma surveillance Stage IV metastatic melanoma
- Stage IV metastatic melanoma
- Ocular melanoma, mucosal melanoma
- Participation in another clinical trial or study involving MSP
- A past history of other cancers is not an exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D or 3D Melanoma Surveillance PhotographyTotal body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy. | Device | Standard of Care plus Melanoma Surveillance Photography |
Primary outcome
Diagnostic performance of melanoma surveillance
Time frame: 24 months
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.
5 secondary outcomes
Cost-effectiveness of MSP
Time frame: 24 months
Diagnostic performance for melanoma
Time frame: 24 months
Diagnostic performance for keratinocyte lesions
Time frame: 24 months
Health-Related Quality of life
Time frame: 24 months
Patient anxiety
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Derived from this study: PubMed 36991460Yan MK, Cust AE, Soyer HP, Janda M, Loewe K, Byars G, Fishburn P, White P, Mahumud RA, Saw RPM, Herschtal A, Fernandez-Penas P, Guitera P, Morton RL, Kelly J, Wolfe R, Mar VJ. Study protocol for a randomised controlled trial to evaluate the use of melanoma surveillance photography to the Improve early detection of MelanomA in ultra-hiGh and high-risk patiEnts (the IMAGE trial). Trials. 2023 Mar 29;24(1):236. doi: 10.1186/s13063-023-07203-5.
- Detailed information on the IMAGE trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Mar principal investigator
Monash University and Alfred Health
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D or 3D Melanoma Surveillance Photography in people with Melanoma and Skin Cancer, run by Melanoma and Skin Cancer Trials Limited at 12 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of melanoma surveillance (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04385732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.