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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Cytophone, which detects skin cancer cells in the blood without needles or cuts. It aims to identify the risk of melanoma spreading or returning earlier than current methods. The trial will evaluate if the Cytophone can effectively track melanoma cells and predict disease progression. Individuals diagnosed with melanoma who can sit for up to an hour might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could revolutionize early melanoma detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Cytophone is safe for diagnosing skin cancer?

Research has shown that the Cytophone is a safe and non-invasive method for detecting melanoma cells in the blood. This device uses a laser to scan blood vessels at a level safe for humans. It requires no injections or cuts, reducing the risk of typical side effects. Previous studies reported no major negative effects, indicating the procedure is well-tolerated. The device's capability to examine large volumes of blood without harm represents a promising advance in early melanoma detection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cytophone for skin cancer because it offers a noninvasive and innovative approach to detecting the disease. Unlike traditional methods such as biopsies or visual inspections, which can be invasive or subjective, Cytophone uses laser technology to safely and painlessly irradiate blood vessels and detect cancer cells. This method not only promises a faster way to identify skin cancer but also minimizes discomfort and risk for patients. By focusing on laser-based detection, Cytophone represents a significant leap forward in skin cancer diagnostics.

What evidence suggests that the Cytophone is effective for diagnosing melanoma metastasis risk?

Research has shown that the Cytophone device, which participants in this trial will experience, can accurately detect melanoma cells in the blood. One study found that it identified cancer cells in 27 out of 28 people with melanoma. The device examines a much larger volume of blood than traditional tests, increasing the likelihood of detecting rare cancer cells. It operates without injections or incisions, making it completely non-invasive. This early detection could help predict the risk of melanoma spreading or recurring. ^{1 2 3 6 7}

Who Is on the Research Team?

Ekaterina Galanzha, PhD

Principal Investigator

Cytoastra

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9235419/

In vivo liquid biopsy using Cytophone platform for ... These data suggest the potential of in vivo blood testing with the Cytophone for early melanoma screening, assessment of disease recurrence, and ...

2. cancer.gov cancer.gov/news-events/cancer-currents-blog/2019/cytophone-detects-melanoma-cells-in-blood

Cytophone Device Detects, Kills Melanoma Cells in the ... The device, which the investigators call Cytophone, accurately detected cancer cells in 27 out of 28 people with melanoma.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06488365

NCT06488365 | In Vivo Liquid Biopsy of Melanoma ... 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.

4. nature.com nature.com/articles/s41598-022-11452-w

Towards rainbow portable Cytophone with laser diodes for ... In vivo, Cytophone has demonstrated the capability for the early diagnosis of cancer, infection, and cardiovascular disorders through ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06488365/in-vivo-liquid-biopsy-of-melanoma-cytophone

In Vivo Liquid Biopsy of Melanoma (Cytophone) 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 ...

6. withpower.com withpower.com/trial/phase-neoplastic-cells-circulating-8-2024-80df2

Cytophone for Skin Cancer · Recruiting Participants ... 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 ...

7. ctv.veeva.com ctv.veeva.com/study/in-vivo-liquid-biopsy-of-melanoma-melanoma-cytophone

In Vivo Liquid Biopsy of Melanoma (Cytophone) 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 ...