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

Pilot Study to Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth

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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Pigmented Skin Lesion
• Intervention / Treatment: Device: Functional photoacoustic microscopy; Procedure: Standard of care surgical excision; Device: Single cell photoacoustic microscopy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm 1: fPAM imaging & Single cell PAM imaging; 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

Device: Functional photoacoustic microscopy; -Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.; Other Names: fPAM; Procedure: Standard of care surgical excision; Device: Single cell photoacoustic microscopy; Other Names: Single cell PAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In vivo studies using fPAM pigmented lesions imaging to measure tumor depth		Up to 2 weeks
Validate the lesion depth estimated by fPAM	-The thickness as measured by fPAM will be compared with the thickness of the formalin fixed excised lesion.	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Feasibility and functionality of fPAM as measured by CTC detection	Up to 2 weeks
Feasibility and functionality of single-cell PAM as measured by CTC detection	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Lynn Cornelius, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2015
• Primary Completion (Actual): June 27, 2017
• Study Completion (Actual): June 27, 2017

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Imaging; Melanoma; Pigmented Lesions; Melanoma Management
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Pigmentation Disorders
• Other Study ID Numbers: 201410125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No