NCT02613325

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

Completed Phase 1 Last updated 14 February 2018

What this trial tests

Phase 1 trial testing Functional photoacoustic microscopy in Pigmented Skin Lesion in 24 participants. Completed in 27 June 2017.

Timeline

8 June 2015

Primary endpoint
27 June 2017

27 June 2017

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	24
Start date	8 June 2015
Primary completion	27 June 2017
Estimated completion	27 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Functional photoacoustic microscopy
• Standard of care surgical excision
• Single cell photoacoustic microscopy

Conditions studied

• Pigmented Skin Lesion — all drugs for Pigmented Skin Lesion →
• Melanoma — all drugs for Melanoma →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Pigmented Skin Lesion or Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stimuli-activatable nanomedicine meets cancer theranostics.
   Li H, Feng Y, Luo Q, Li Z, et al · · 2023 · cited 108× · PMID 37908735 · DOI 10.7150/thno.87854
2. Label-free high-throughput photoacoustic tomography of suspected circulating melanoma tumor cells in patients in vivo.
   Hai P, Qu Y, Li Y, Zhu L, et al · · 2020 · cited 27× · PMID 32170857 · DOI 10.1117/1.jbo.25.3.036002