MelaFind Evaluations for Patients With Multiple Nevi

Clinically Atypical Pigmented Skin Lesion Clinical Trial

Official title:

MelaFind Evaluations for Patients With Multiple Nevi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700101
• Other study ID #: 20123
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: August 25, 2014
• Start date: November 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: MELA Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

We have added objectives 4-6 to our updated study:

Study Objective 1: To determine whether the distribution of MelaFind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient.

Study Objective 2: To investigate whether distributions of quantitative ABCD parameters differ among patients and whether these qABCD parameters identify "signature" lesions.

Study Objective 3: To determine the feasibility of defining and using relative thresholds to improve the specificity of MelaFind without sacrificing its high sensitivity.

Study Objective 4: To determine the repeatability of MelaFind scores for a given lesion for different patient and lesion characteristics.

Study Objective 5: To identify patient and lesion characteristics that result in the highest variability of MelaFind scores for a given lesion.

Study Objective 6: To use standard errors of MelaFind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Cutaneous lesions examined with MelaFind must satisfy all of the following inclusion criteria:

Inclusion Criteria:

• The lesion is pigmented (i.e., melanin, keratin, blood)

• The diameter of the pigmented area is not < 2 mm, and not > 22 mm

• The lesion is accessible to the MelaFind

• The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form;

Cutaneous lesions that meet any of the following exclusion criteria will not be accepted:

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Clinically Atypical Pigmented Skin Lesion
• Pigmentation Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MELA Sciences, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple values and standard deviations of MelaFind scores for pigmented skin lesions		1 month	No