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NCT02613325 · ClinicalTrials.gov registry record · Phase 1
fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02613325 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 24 participants.
The verdict
NCT02613325, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Functional photoacoustic microscopy
- PROCEDURE Standard of care surgical excision
- DEVICE Single cell photoacoustic microscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-06-08 |
| Est. Completion | 2017-06-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02613325
The ClinicalTrials.gov registry entry for NCT02613325 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Functional photoacoustic microscopy is the first listed.
NCT02613325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02613325 about?
NCT02613325 is a clinical study titled "fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth". 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 d...
What is the current status of trial NCT02613325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-06-08. Estimated completion is 2017-06-27.
What interventions are being tested in trial NCT02613325?
The interventions under investigation include: Functional photoacoustic microscopy (DEVICE), Standard of care surgical excision (PROCEDURE), Single cell photoacoustic microscopy (DEVICE).
Who is sponsoring clinical trial NCT02613325?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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