fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
NCT ID: NCT02613325
Last Updated: 2018-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2015-06-08
2017-06-27
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
Functional photoacoustic microscopy
-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.
Standard of care surgical excision
Single cell photoacoustic microscopy
Interventions
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Functional photoacoustic microscopy
-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.
Standard of care surgical excision
Single cell photoacoustic microscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* ECOG status \> 3
18 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Lynn Cornelius, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201410125
Identifier Type: -
Identifier Source: org_study_id
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