RecruitingNot ApplicableNCT06488365

In Vivo Liquid Biopsy of Melanoma (Cytophone)

In Vivo Liquid Biopsy for Early Detection of Metastatic Melanoma

Sponsor

Cytoastra

Enrollment

180 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Melanoma Metastatic Melanoma Diagnosis Circulating Tumor Cells

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive device called Cytophone that uses laser pulses and sound waves to detect melanoma cells in the bloodstream — like a liquid biopsy without a needle. Researchers want to see if this device can accurately find circulating cancer cells in people with melanoma. **You may be eligible if...** - You have a confirmed diagnosis of melanoma - You are able to sit still for up to 60 minutes - You are willing and able to give informed consent **You may NOT be eligible if...** - You are unable to give informed consent due to a mental health condition - You have significant cardiovascular, liver, or neurological problems - You have conditions that could interfere with the device readings Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECytophone

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.