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

February 13, 2018 updated by: Washington University School of Medicine

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 2 weeks
Up to 2 weeks
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.
Up to 2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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