fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth

The Washington University

Status and phase: Completed; Phase 1

Conditions: Melanoma; Pigmented Skin Lesion

Treatments: Procedure: Standard of care surgical excision; Device: Functional photoacoustic microscopy; Device: Single cell photoacoustic microscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02613325

201410125

Details and patient eligibility

About

The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma, tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma diagnosis and management - potentially an earlier and more definitive surgical management.

In addition, the investigators propose to use the combination of fPAM and single-cell PAM to respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators' murine models, the investigators anticipate that they will be able to differentiate CTCs from other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Outcome Measure #1 and #2

• Healthy individuals with pigmented lesions or a partially biopsied melanoma whose treatment plan includes excision
• Participants must be 18 years or older
• Participants must be able to understand and willing to sign a written informed consent document

Outcome Measures #3 and #4

• Patients with either cutaneous, visceral or brain melanoma metastases.
• Participants must be 18 years or older.
• Participants must be Eastern Cooperative Oncology Group (ECOG) status 0-3.
• Participants must be able to understand and willing to sign a written informed consent document.

Exclusion criteria

• Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from this study
• ECOG status > 3

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Arm 1: fPAM imaging & Single cell PAM imaging

Experimental group

Description:

* fPAM imaging will be performed prior to scheduled excision. The time to excision will not be extended longer than 2 weeks for imaging purposes. * When the participant presents for imaging, the area of the thickest lesion depth will be determined by fPAM. The area of deepest thickness will be marked perpendicular to the longest axis of the lesions and a clinical photo will be taken and placed in the image storage database. * Surgical excision will be performed as standard of care and fPAM depth will be compared with histological examination. * To image CTCs in cutaneous blood vessels, a small cuticle area on a finger will be imaged (Single cell PAM imaging) and the most distal cutaneous metastasis or metastasis of largest diameter will be imaged

Treatment:

Device: Single cell photoacoustic microscopy

Device: Functional photoacoustic microscopy

Procedure: Standard of care surgical excision