In Vivo Liquid Biopsy of Melanoma (Cytophone)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCytoastra
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Unable to provide informed consent to participate in the study, such as a mental condition rendering the participant unable to understand the nature, scope, and possible consequences of the study;
Clinically relevant cardiovascular, hepatic, neurological (e.g., evidence of organic brain syndrome), endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the participant at risk by participating in the study;
Persistent significant or severe infection, either acute or chronic;
Pregnant or breast-feeding women or those who plan to become pregnant during the study;
Trial design
Design model
Single group
Treatments tested in this trial
Cytophone
DeviceThe 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.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: Cytophone applicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Identify and count CTCs in blood in vivo
Link CTC counts with early melanoma progression and recurrence efficacy
Time frame
nine months Source ClinicalTrials.gov