In Vivo Liquid Biopsy of Melanoma (Cytophone)

NCT06488365 | Recruiting FDA Device

• 1 other identifier: Pro00075507
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Identify and count CTCs in blood in vivo

  Link CTC counts with early melanoma progression and recurrence efficacy

  nine months

Study Arms (1)

Cytophone application

EXPERIMENTAL

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.

Device: Cytophone

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.

Also known as: Photoacoustiv flow cytometry (PAFC) in vivo

Cytophone application

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cytoastra: lead

Study Sites (1)

SSM Health Dean Medical Group Specialty Services

Madison, Wisconsin, 53715, United States

RECRUITING

Related Publications (3)

• Galanzha EI, Shashkov EV, Spring PM, Suen JY, Zharov VP. In vivo, noninvasive, label-free detection and eradication of circulating metastatic melanoma cells using two-color photoacoustic flow cytometry with a diode laser. Cancer Res. 2009 Oct 15;69(20):7926-34. doi: 10.1158/0008-5472.CAN-08-4900. Epub 2009 Oct 13.

  PMID: 19826056 BACKGROUND

• Galanzha EI, Zharov VP. Circulating Tumor Cell Detection and Capture by Photoacoustic Flow Cytometry in Vivo and ex Vivo. Cancers (Basel). 2013 Dec 10;5(4):1691-738. doi: 10.3390/cancers5041691.

  PMID: 24335964 BACKGROUND

• Galanzha EI, Menyaev YA, Yadem AC, Sarimollaoglu M, Juratli MA, Nedosekin DA, Foster SR, Jamshidi-Parsian A, Siegel ER, Makhoul I, Hutchins LF, Suen JY, Zharov VP. In vivo liquid biopsy using Cytophone platform for photoacoustic detection of circulating tumor cells in patients with melanoma. Sci Transl Med. 2019 Jun 12;11(496):eaat5857. doi: 10.1126/scitranslmed.aat5857.

  PMID: 31189720 RESULT

MeSH Terms

Conditions

Melanoma; Neoplastic Cells, Circulating; Disease; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ekaterina Galanzha, PhD

  Cytoastra

  STUDY DIRECTOR

Central Study Contacts

James Golleher, MBA

CONTACT

5017658175; jgolleher@cytoastra.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All study participants will be blinded from their results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy subjects and melanoma patients will be tested in this study. All subjects will receive the same Cytophone intervention (testing). Healthy subjects will receive one Cytophone test, and melanoma patients will receive four tests. There will be four cohorts to the study: Cohort 1: 30 healthy subjects to address the calibration purpose. Cohort 2: 50 stage 0-I melanoma patients to link the presence of CTCs in blood circulation or increase in CTC count with metastatic disease initiation. Cohort 3: 50 stage II melanoma patients to define the correlation between CTC count and metastatic disease initiation/progression and further recurrence. Cohort 4: 50 stage III-IV melanoma patients to link CTC counts, metastatic disease progression and therapy efficiency.

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: February 11, 2025
• Primary Completion: February 11, 2026
• Study Completion: March 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)