Cytophone for Skin Cancer

(Cytophone Trial)

Overseen By James Golleher, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cytoastra

Disqualifiers: Cardiovascular, Hepatic, Neurological, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

180 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Ekaterina Galanzha, PhD

Principal Investigator

Cytoastra

Eligibility Criteria

This trial is for individuals with a confirmed diagnosis of melanoma who can sit still for up to an hour and have signed an informed consent form. The full eligibility criteria are not provided, so additional requirements may apply.

Inclusion Criteria

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

I can sit for an hour without needing to get up.

My diagnosis of melanoma is confirmed by tissue analysis.

Exclusion Criteria

Pregnant or breast-feeding women or those who plan to become pregnant during the study

I do not have major health issues that would risk my participation in 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cytophone Application

Participants undergo the Cytophone diagnostic procedure, including ultrasound imaging and noninvasive laser irradiation for CTC detection

1 day

1 visit (in-person)

Monitoring

Participants are monitored for CTC counts to assess early melanoma progression and recurrence

9 months

Follow-up

Participants are monitored for safety and effectiveness after the Cytophone application

4 weeks

Treatment Details

Interventions

• Cytophone

Trial Overview The Cytophone system is being tested; it's a non-invasive device that detects circulating melanoma cells in the blood, potentially indicating metastasis risk and monitoring disease progression or treatment effectiveness.

Participant Groups

Group I: Cytophone application Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Cytoastra

Lead Sponsor

Trials

1

Recruited

180+