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
Verified date | February 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
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 |
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