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

Primary Purpose

Pigmented Skin Lesion, Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Functional photoacoustic microscopy
Standard of care surgical excision
Single cell photoacoustic microscopy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pigmented Skin Lesion focused on measuring Melanoma, Imaging, Pigmented Lesions, Melanoma Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: fPAM imaging & Single cell PAM imaging

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2015
Last Updated
February 13, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02613325
Brief Title
fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
Official Title
Pilot Study to Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 8, 2015 (Actual)
Primary Completion Date
June 27, 2017 (Actual)
Study Completion Date
June 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigmented Skin Lesion, Melanoma
Keywords
Melanoma, Imaging, Pigmented Lesions, Melanoma Management

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: fPAM imaging & Single cell PAM imaging
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Functional photoacoustic microscopy
Other Intervention Name(s)
fPAM
Intervention Description
-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.
Intervention Type
Procedure
Intervention Name(s)
Standard of care surgical excision
Intervention Type
Device
Intervention Name(s)
Single cell photoacoustic microscopy
Other Intervention Name(s)
Single cell PAM
Primary Outcome Measure Information:
Title
In vivo studies using fPAM pigmented lesions imaging to measure tumor depth
Time Frame
Up to 2 weeks
Title
Validate the lesion depth estimated by fPAM
Description
-The thickness as measured by fPAM will be compared with the thickness of the formalin fixed excised lesion.
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Feasibility and functionality of fPAM as measured by CTC detection
Time Frame
Up to 2 weeks
Title
Feasibility and functionality of single-cell PAM as measured by CTC detection
Time Frame
Up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Cornelius, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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