fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
Pigmented Skin Lesion, Melanoma
About this trial
This is an interventional diagnostic trial for Pigmented Skin Lesion focused on measuring Melanoma, Imaging, Pigmented Lesions, Melanoma Management
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Experimental
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