MelanomaNCT02470273
Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
An observational study of Melanoma, run by Rockefeller University at 5 sites in United States.
Trial summary
The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma
- How many people
- 143 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2015to 11 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dermatology patients with a suspicious lesion that will be biopsied as standard of care
Who may be able to join
- Participant has normal appearing skin and a suspicious pigmented lesion.
Who cannot join
- Lesion near the eyes (due to safety)
- Inaccessibility to lesion related to device: ears, toes, fingers, nailbeds, ankles, elbows, genitals
- Self-reported history of photosensitivity
- Self-reported history of vitiligo and/or other sun sensitive disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beckman Laser Institute at University of California Irvine
Irvine, California, 92617
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Skin and Cancer Associates
Plantation, Florida, 33324
Oregon Health Sciences University
Portland, Oregon, 97239
The University of California (Davis)
Sacramento, California, 95816
About this study
Official title: Multicenter Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.
Read the detailed description
The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.
The scientific hypothesis is that the diagnostic mechanism for superficial melanoma is the light tissue interaction that occurs between the blue shifted wavelengths (i.e. blue light, ultra violet light) and the superficial epidermis while the mechanism for diagnosis of deeper melanoma (i.e. Breslow depth >0.5mm) is the light/tissue interaction that occurs between the red shifted light (i.e. red light, infrared light) and the portion of the pigmented lesion that lies within the dermis. These hypotheses were fueled by initial observations that the diagnostic sensitivity and specificity were wavelength dependent in a study that looked at only the red, green and blue wavelengths as available in traditional digital dermoscopy imaging. The initial finding was that of the multiple features analyzed, more features were statistically significant diagnostics in the blue channel but there were (a relative minority) other features that fared better in the red channel. It is hypothesized that the diagnostic features that did better in the red channel were features of deep melanin while the superficial regions, which should theoretically be atypical in ALL melanomas, were evident in the quantitative endpoint metrics generated from the blue channel.
- Conditions
- Melanoma
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dermatology patients | Patients with a suspicious skin lesion indicated for biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison between gold standard histopathology screening results and mAID screening results
A comparison between the gold standard invasive biopsy diagnostic result (melanoma or nevus) and the diagnostic result produced by automated computer image processing that operates on the mAID-produced hyperspectral image. This diagnostic result is defined as the melanoma Q-score, which is the percent likelihood that this lesion is melanoma based on a previous computer-learning algorithm that utilized 53 unique malignancy metrics.
Measured: Day 1
Secondary outcomes (1)
A comparison between gold standard histopathology screening results and analysis of the standard dermatoscope image.
A comparison between the gold standard invasive biopsy diagnostic result (melanoma or nevus) and the diagnostic result produced by automated computer image processing that operates on the standard dermatoscope image. This diagnostic result is defined as the melanoma Q-score, which is the percent likelihood that this lesion is melanoma based on a previous computer-learning algorithm that utilized 53 unique malignancy metrics.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start1 Aug 2015
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, University of California, Irvine, Skin and Cancer Associates
- Responsible party
- Sponsor
- Investigators
- Daniel Gareau, PhD, MCR, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470273
- Sponsor's protocol ID
- DGA-0860
- Other IDs
- Q141095
- Status last verified
- May 2023
- First submitted
- 4 Jun 2015
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)
- ClinicalTrials.gov ID
- NCT02470273
- Acronym / sponsor ID
- DGA-0860
- Conditions
- Melanoma
- Keywords
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, University of California, Irvine, Skin and Cancer Associates
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.
Detailed description
The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.
The scientific hypothesis is that the diagnostic mechanism for superficial melanoma is the light tissue interaction that occurs between the blue shifted wavelengths (i.e. blue light, ultra violet light) and the superficial epidermis while the mechanism for diagnosis of deeper melanoma (i.e. Breslow depth >0.5mm) is the light/tissue interaction that occurs between the red shifted light (i.e. red light, infrared light) and the portion of the pigmented lesion that lies within the dermis. These hypotheses were fueled by initial observations that the diagnostic sensitivity and specificity were wavelength dependent in a study that looked at only the red, green and blue wavelengths as available in traditional digital dermoscopy imaging. The initial finding was that of the multiple features analyzed, more features were statistically significant diagnostics in the blue channel but there were (a relative minority) other features that fared better in the red channel. It is hypothesized that the diagnostic features that did better in the red channel were features of deep melanin while the superficial regions, which should theoretically be atypical in ALL melanomas, were evident in the quantitative endpoint metrics generated from the blue channel.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermatology patients | – | –Patients with a suspicious skin lesion indicated for biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dermatology patients with a suspicious lesion that will be biopsied as standard of care
Key inclusion criteria (1 listed)
- Participant has normal appearing skin and a suspicious pigmented lesion.
Key exclusion criteria (4 listed)
- Lesion near the eyes (due to safety)
- Inaccessibility to lesion related to device: ears, toes, fingers, nailbeds, ankles, elbows, genitals
- Self-reported history of photosensitivity
- Self-reported history of vitiligo and/or other sun sensitive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A comparison between gold standard histopathology screening results and mAID screening results
Time frame: Day 1
A comparison between the gold standard invasive biopsy diagnostic result (melanoma or nevus) and the diagnostic result produced by automated computer image processing that operates on the mAID-produced hyperspectral image. This diagnostic result is defined as the melanoma Q-score, which is the percent likelihood that this lesion is melanoma based on a previous computer-learning algorithm that utilized 53 unique malignancy metrics.
1 secondary outcome
A comparison between gold standard histopathology screening results and analysis of the standard dermatoscope image.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- 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.
Daniel Gareau, PhD, MCR principal investigator
Rockefeller University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Rockefeller University at 5 sites in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A comparison between gold standard histopathology screening results and mAID screening results (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.