Study of the Nevisense Device to Assess Atypical Skin Lesions

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Multiple Nevi; Large Acquired Nevi; Nevus; Skin Lesion

Treatments: Diagnostic Test: Nevisense electrical impedance spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04705168

21-010

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (> 30 years of age) at the time of the initial study visit.
• 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.
• Patients with at least three clinically stable nevi between 5 and 20 mm in diameter.
• Patients (or LAR) who are able to provide informed consent.
• Patients with previous total body photography images taken at least 3 years prior

Exclusion criteria

• Patients without at least three clinically stable nevi between 5 and 20 mm in diameter.
• Patients with any electronic implantable devices.
• Patients who are pregnant (verbally confirmed with the participant).

Trial design

40 participants in 1 patient group

Participants displaying nevi

Description:

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.

Treatment:

Diagnostic Test: Nevisense electrical impedance spectroscopy