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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613325
• Other study ID #: 201410125
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2015
• Last updated: February 13, 2018
• Start date: June 8, 2015
• Est. completion date: June 27, 2017

Study information

• Verified date: February 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Pigmentation Disorders
• Pigmented Skin Lesion

Intervention

Device:
• Functional photoacoustic microscopy
-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.

Procedure:
• Standard of care surgical excision

Device:
• Single cell photoacoustic microscopy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In vivo studies using fPAM pigmented lesions imaging to measure tumor depth		Up to 2 weeks
Primary	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	Feasibility and functionality of fPAM as measured by CTC detection		Up to 2 weeks
Secondary	Feasibility and functionality of single-cell PAM as measured by CTC detection		Up to 2 weeks

External Links

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