In Vivo Liquid Biopsy of Melanoma (Cytophone)

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Cytoastra
Study ID
NCT06488365
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Cytophone — DEVICE
    The Cytophone clinical prototype incorporates two pulse lasers, optical system for delivery of laser light to the skin, ultrasound transducer array and detection electronics for acquisition of acoustic waves from CTCs. Parameters of lasers: C-Wedge 1064 (Bright Solutions, Cura Carpignano (PV), Italy): Wavelength,1064 nm; pulse width, 0.6 ns; pulse rate: 1 kHz; pulse energy, 240 μJ. C-Wedge 18901 (Bright Solutions, Cura Carpignano (PV), Italy): Wavelength, 770 nm; pulse width 3 ns; pulse rate, 1 kHz; pulse energy, 240 μJ. Detection of acoustic waves from CTCs is performing by a focused ultrasound transducer array placed in an acoustic contact with the skin of the subject with ultrasound gel. The signals from the transducers are amplified with a 16 channel amplifier, then digitized by a 12-bit, 500 MSPS high speed board digitizer (ATS9350, AlazarTech, Canada). This information is then transferred to a data recording system using a secure computer.

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
Mar 2025
Primary completion
Feb 11, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Identify and count CTCs in blood in vivo [ Time Frame: nine months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SSM Health Dean Medical Group Specialty ServicesMadisonWisconsin53715
Lisa Lepeak, MD
Lisa Lepeak, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Madison, WI

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
SSM Health Dean Medical Group Specialty Services· Madison, WI

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