Melanoma
Conditions
Keywords
Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind
Brief summary
The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.
Interventions
DEVICEMelaFind(R)
Biopsy ratio comparison
Sponsors
MELA Sciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* The lesion is pigmented (i.e., melanin, keratin, blood) * Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion * The diameter of the pigmented area is between 2 and 22 millimeters * The lesion is accessible to the MelaFind hand-held imaging device * The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form
Exclusion criteria
* The patient has a known allergy to isopropyl alcohol * The lesion has been previously biopsied, excised, or traumatized * The skin is not intact (e.g., open sores, ulcers, bleeding) * The lesion is within 1 cm of the eye * The lesion is on mucosal surfaces (e.g., lips, genitals) * The lesion is on palmar hands * The lesion is on plantar feet * The lesion is on or under nails * The lesion is located on or in an area of visible scarring * The lesion contains foreign matter (e.g., tattoo, splinter, marker)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | Within 120 days of Data Lock | Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy Ratio | Within 120 days of Data Lock | Number of lesions bioopsied to melanomas detected |
| Exploratory Analyses | Within 365 days of Data Lock | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biopsied Pigmented Skin Lesions Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto | 1,383 |
| Total | 1,383 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Biopsied Pigmented Skin Lesions |
|---|---|
| Age, Categorical <=18 years | 56 Participants |
| Age, Categorical >=65 years | 271 Participants |
| Age, Categorical Between 18 and 65 years | 1056 Participants |
| Age Continuous | 48 years STANDARD_DEVIATION 18.3 |
| Region of Enrollment United States | 1383 participants |
| Sex: Female, Male Female | 745 Participants |
| Sex: Female, Male Male | 638 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,383 |
| serious Total, serious adverse events | 0 / 1,383 |
Outcome results
Primary
Sensitivity and Specificity
Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.
Time frame: Within 120 days of Data Lock
Population: All participants with eligible and evaluable lesions were used in analysis of primary outcome measures
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Biopsied Pigmented Skin Lesions | Sensitivity and Specificity | MelaFind sensitivity to melanoma | 98.2 Ratio * 100 |
| Biopsied Pigmented Skin Lesions | Sensitivity and Specificity | MelaFind specificity for melanoma | 9.5 Ratio * 100 |
Comparison: MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.p-value: 0.0595% CI: [95.1, 100]exact mid-P
Comparison: Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.p-value: 0.02Chi-squared
Secondary
Biopsy Ratio
Number of lesions bioopsied to melanomas detected
Time frame: Within 120 days of Data Lock
Secondary
Exploratory Analyses
Time frame: Within 365 days of Data Lock