In Vivo Liquid Biopsy of Melanoma (Cytophone)

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.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

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.

• BACKGROUNDGalanzha 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
• BACKGROUNDGalanzha 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
• RESULTGalanzha 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