Recruiting

Cytophone

Sponsor:

Cytoastra

Code:

NCT06488365

Conditions

Melanoma

Circulating Tumor Cells

Metastatic Melanoma

Diagnosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Cytophone

Study Details

Brief 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.

Conditions

Melanoma

Circulating Tumor Cells

Metastatic Melanoma

Diagnosis

Study ID

NCT06488365

Start date

Feb 11, 2025

Status verified date

Mar, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Feb 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy;
  • Any known history of severe preexisting constipation.

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Cytophone

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

James Golleher, MBA

5017658175jgolleher@cytoastra.com

Locations

SSM Health Dean Medical Group Specialty Services

Recruiting

Madison, Wisconsin, United States, 53715

Principal Investigator:

Lisa Lepeak, MD

More Information

Sponsor

Cytoastra

Last update posted

Mar 11, 2025

Last verified

Mar, 2025

Keywords

  • melanoma
  • circulating tumor cells (CTCs)
  • in vivo liquid biopsy
  • metastasis
  • diagnosis and prognosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cytoastra on 2025-03-11.