Phase 3
N=1,383
Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00434057 ↗Enrolled (actual)
1,383
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Sensitivity and Specificity — 98.2; 9.5 Ratio * 100 — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MelaFind(R) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- MELA Sciences, Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity |
98.2; 9.5 | 0.05 |
| SECONDARY Biopsy Ratio |
— | — |
| SECONDARY Exploratory Analyses |
— | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00434057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.