MelanomaPhase 3NCT00434057

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

A Phase 3 study testing MelaFind(R) in people with Melanoma, run by MELA Sciences, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Melanoma
What is being tested?: MelaFind(R)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,383 participants
Where: 2 sitesUnited States
Study dates: Jan 2007to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Skin and Cancer Associates
Plantation, Florida, 33324
Dermatology Associates of Tallahassee
Tallahassee, Florida, 32317

Other trials in United States

About this study

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.

Conditions: Melanoma
Being tested: MelaFind(R)
Keywords: Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind
Medical subject headings: Melanoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MelaFind(R)Device
Also called MF100, MelaFind Device System, MelaFind Device
Biopsy ratio comparison

Study groups in NCT00434057
Study group	Role	What they receive
Biopsied Pigmented Skin Lesions	Other	Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto Receives: Device: MelaFind(R)

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity and Specificity
Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.
Measured: Within 120 days of Data Lock

Secondary outcomes (2)

Biopsy Ratio
Number of lesions bioopsied to melanomas detected
Measured: Within 120 days of Data Lock
Exploratory Analyses
Measured: Within 365 days of Data Lock

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jul 2008

First posted12 Feb 2007 (estimated)
Study startJan 2007
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00434057
Sponsor's protocol ID: 20061
Status last verified: Feb 2012
First submitted: 8 Feb 2007
Last updated: 14 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Monheit G, Cognetta AB, Ferris L, Rabinovitz H, Gross K, Martini M, Grichnik JM, Mihm M, Prieto VG, Googe P, King R, Toledano A, Kabelev N, Wojton M, Gutkowicz-Krusin D. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. 2011 Feb;147(2):188-94. doi: 10.1001/archdermatol.2010.302. Epub 2010 Oct 18.
PubMed 20956633

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Pigmented Skin Lesions With MelaFind(R) System
ClinicalTrials.gov ID: NCT00434057
Acronym / sponsor ID: 20061
Conditions: Melanoma
Keywords: Pigmented Skin Lesions, Dermatology, Skin Cancer, Melanoma, MelaFind
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,383 participants (actual)
Lead sponsor: MELA Sciences, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 12 Feb 2007 (estimated)
Results: Posted 11 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Biopsied Pigmented Skin Lesions	Other	Device: MelaFind(R)Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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)

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
MelaFind(R)Also: MF100, MelaFind Device System, MelaFind DeviceBiopsy ratio comparison	Device	Biopsied Pigmented Skin Lesions

Primary outcome

Sensitivity and Specificity
Time frame: 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.

2 secondary outcomes

Biopsy Ratio
Time frame: Within 120 days of Data Lock
Exploratory Analyses
Time frame: Within 365 days of Data Lock

Results and safety

Results posted to the registry on 11 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biopsied Pigmented Skin Lesions	1,383	1,382

Primary outcome: Sensitivity and Specificity

Time frame: Within 120 days of Data Lock. Mean (95% Confidence Interval). Unit: Ratio * 100

Measure	Biopsied Pigmented Skin Lesions n = 1257
MelaFind sensitivity to melanoma	98.2 (95.1 to 100)
MelaFind specificity for melanoma	9.5 (6.1 to 12.9)

Biopsied Pigmented Skin Lesions: Sensitivity to melanoma: 98 (95% CI 95.1 to 100), p = 0.05, exact mid-P
Biopsied Pigmented Skin Lesions: p = 0.02, Chi-squared

Population analysed: All participants with eligible and evaluable lesions were used in analysis of primary outcome measures

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biopsied Pigmented Skin Lesions	0 of 1,383 (0%)	0 of 1,383 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20956633Monheit G, Cognetta AB, Ferris L, Rabinovitz H, Gross K, Martini M, Grichnik JM, Mihm M, Prieto VG, Googe P, King R, Toledano A, Kabelev N, Wojton M, Gutkowicz-Krusin D. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. 2011 Feb;147(2):188-94. doi: 10.1001/archdermatol.2010.302. Epub 2010 Oct 18.
Sponsor Web SiteLink provided by the sponsor.

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Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
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RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
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Active, not recruitingPhase 1/2
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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.

Dina Gutkowicz-Krusin, PhD study director

Electro-Optical Sciences, Inc.

Joseph V Gulfo, MD, MBA study director

Electro-Optical Sciences, Inc.

Harold S Rabinovitz, MD study chair

Skin and Cancer Associates

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MelaFind(R) in people with Melanoma, run by MELA Sciences, Inc. at 2 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 5 inclusion and 10 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 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sensitivity and Specificity (time frame: Within 120 days of Data Lock). 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 NCT00434057, 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 14 Feb 2012.