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The objective of this clinical trial is to determine whether a Photoacoustic flow cytometry (PAFC)-based prototype device can detect circulating tumor cells (CTCs) in the blood of melanoma patients in vivo, in real time, and do so at detection limits at least one order of magnitude below the detection limits of currently existing ex vivo methods.
Study Population: Approximately 80 subjects will be consented in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts as follows:
Subjects in cohort #3 will be used to address the detection goal of Specific Aim #3. Approximately 10 of the 30 early-stage subjects will be Stage I and approximately 20 will be Stage II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control subjects | Characterize the baseline PA signals produced by the in vivo PAFC prototype device in healthy volunteers or Develop Standard Curves for the ex vivo CTC assays. | ||
| Advanced-Stage Melanoma | To validate the in vivo PAFC method of melanoma CTC detection, we will use the PAFC-based prototype device to noninvasively determine CTC concentrations in the blood of subjects who have advanced-stage (Stage III or Stage IV)melanoma, and we will also use current ex vivo methods to determine the CTC concentration in samples of blood drawn from the same subjects. | ||
| Early-Stage Melanoma | To determine whether in vivo PAFC can detect melanoma CTCs at concentrations below the detection limits of the ex vivo methods, we will use the PAFC-based prototype device to noninvasively detect CTCs in the blood of subjects who have early-stage (Stages I or II) melanoma, and we will also use current ex vivo methods to detect CTCs in samples of blood drawn from the same subjects. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that possess circulating tumor cells. | 14-21 days |
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Inclusion Criteria:
Exclusion Criteria:
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Expect to consent approximately 80 subjects in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jumin Sunde, MD | Contact | 501-526-6990 | Jsunde2@uams.edu | |
| Daniel Dunham | Contact | 5016868274 | ddunham@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jumin Sunde, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |