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

Phase 1

Completed

• Conditions: Melanoma; Pigmented Skin Lesion
• Interventions: Device: Functional photoacoustic microscopy; Procedure: Standard of care surgical excision; Device: Single cell photoacoustic microscopy

• Registration Number: NCT02613325
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-08
• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-24
• Primary Completion: 2017-06-27
• Study Completion: 2017-06-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: fPAM imaging & Single cell PAM imaging	Functional photoacoustic microscopy	* 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
Arm 1: fPAM imaging & Single cell PAM imaging	Standard of care surgical excision	* 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
Arm 1: fPAM imaging & Single cell PAM imaging	Single cell photoacoustic microscopy	* 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

Primary Outcome Measures

Name	Time	Method
In vivo studies using fPAM pigmented lesions imaging to measure tumor depth	Up to 2 weeks
Validate the lesion depth estimated by fPAM	Up to 2 weeks	-The thickness as measured by fPAM will be compared with the thickness of the formalin fixed excised lesion.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States