In Vivo Liquid Biopsy for Early Detection of Metastatic Melanoma

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Cytophone is a first in the world patented system to identify and count single circulating melanoma cells in blood circulation inside the human body. The Cytophone has a unique capability to find rare melanoma cells in the blood by an assessment of 100-500 times greater amounts of blood volume than routine blood tests. The important benefit of the Cytophone diagnosis is that the test does not require injection or any skin incision (i.e., non-invasiveness). The goal of this clinical trial is to demonstrate evidence of the capability of the Cytophone test to indicate a risk of metastasis and define CTC counts that correlate with melanoma recurrence, progression of metastatic disease, and therapy efficacy. The investigators believe that clinical trials will provide evidence that the Cytophone can diagnose risk of melanoma metastasis and recurrence earlier than existing methods.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Histological documented diagnosis of melanoma;

• Participants having provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of all requirements and possible risks;

• Must be able to sit for up to 60 minutes.

Locations
United States
Wisconsin
SSM Health Dean Medical Group Specialty Services
RECRUITING
Madison
Contact Information
Primary
James Golleher, MBA
jgolleher@cytoastra.com
5017658175
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 180
Treatments
Experimental: Cytophone application
It is anticipated that Cytophone diagnostic procedure will start with 30-min preparation including ultrasound imaging of an examined vessel, photo of a skin area above the vessel and quick navigation of the PAFC probe on the vessel using near-infrared viewer. After completion, the Cytophone monitoring will be conducted for 30-60 min and will include noninvasive irradiation of the vessel by a laser beam(s) using a safe for human laser energy level.
Related Therapeutic Areas
Sponsors
Leads: Cytoastra

This content was sourced from clinicaltrials.gov