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Completed

NCT Number: NCT02613325

fPAM 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional photoacoustic microscopy

Device

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

Other names: fPAM

Standard of care surgical excision

Procedure

Single cell photoacoustic microscopy

Device

Other names: Single cell PAM

Primary outcomes

  1. In vivo studies using fPAM pigmented lesions imaging to measure tumor depth

    Time frame: Up to 2 weeks

  2. Validate the lesion depth estimated by fPAM

    Time frame: Up to 2 weeks

    -The thickness as measured by fPAM will be compared with the thickness of the formalin fixed excised lesion.

Secondary outcomes

  1. Feasibility and functionality of fPAM as measured by CTC detection

    Time frame: Up to 2 weeks

  2. Feasibility and functionality of single-cell PAM as measured by CTC detection

    Time frame: Up to 2 weeks

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2015
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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