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

NCT02613325 | Completed Phase 1 DMC FDA Device

• 1 other identifier: 201410125
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pigmented Skin Lesion; Melanoma

Keywords

Melanoma; Imaging; Pigmented Lesions; Melanoma Management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Arm 1: fPAM imaging & Single cell PAM imaging

EXPERIMENTAL

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

Interventions

Functional photoacoustic microscopy DEVICE

-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.

Also known as: fPAM

Arm 1: fPAM imaging & Single cell PAM imaging

Standard of care surgical excision PROCEDURE

Arm 1: fPAM imaging & Single cell PAM imaging

Single cell photoacoustic microscopy DEVICE

Also known as: Single cell PAM

Arm 1: fPAM imaging & Single cell PAM imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lynn Cornelius, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 24, 2015
• Study Start: June 8, 2015
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)