Study of the Nevisense Device to Assess Atypical Skin Lesions
Study Details
Study Description
Brief Summary
The purpose of this study is to find out whether the Nevisense device can provide useful information about atypical moles to complement the usual assessments done during routine screening for melanoma. Assessing particpants' moles with the Nevisense device may help improve screening methods for the early detection of melanoma in people with atypical mole syndrome.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Participants displaying nevi Participants displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study. |
Diagnostic Test: Nevisense electrical impedance spectroscopy
Each participants will undergo Nevisense electrical impedance spectroscopy in order to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter
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Outcome Measures
Primary Outcome Measures
- Electrical impedance spectroscopy scores of participants' nevi [2 weeks]
The primary objective is to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (> 30 years of age) at the time of the initial study visit.
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Patients displaying a phenotype that consists of ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter. These patients have "atypical mole syndrome", which is a high-risk nevus phenotype and the target patient population in this study.
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Patients with at least three clinically stable nevi between 5 and 20 mm in diameter.
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Patients (or LAR) who are able to provide informed consent.
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Patients with previous total body photography images taken at least 3 years prior
Exclusion Criteria:
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Patients without at least three clinically stable nevi between 5 and 20 mm in diameter.
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Patients with any electronic implantable devices.
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Patients who are pregnant (verbally confirmed with the participant).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Memoral Sloan Kettering Basking Ridge (Consent only) | Basking Ridge | New Jersey | United States | 07920 |
2 | Memoral Sloan Kettering Westchester (Consent only) | Harrison | New York | United States | 10604 |
3 | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Ashfaq Marghoob, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-010