Real-time detection of melanoma cells circulating in the blood
In Vivo Real-time Detection of Circulating Melanoma Cells
This project will test whether a new photoacoustic device can find melanoma cells circulating in the blood of adults with early or advanced melanoma and in healthy volunteers in real time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Arkansas Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT01776905 on ClinicalTrials.gov |
What this trial studies
This observational study uses a photoacoustic flow cytometry (PAFC) prototype to look for circulating tumor cells (CTCs) in vivo and in real time. About 75 participants will be enrolled at the University of Arkansas for Medical Sciences across three cohorts: healthy controls, early-stage (I–II) melanoma, and advanced-stage (III–IV) melanoma. Each participant will undergo noninvasive PAFC scanning sessions (participants must be able to sit still for about 90 minutes) to determine device detection limits compared with existing ex vivo methods. The trial aims to show detection sensitivity at least one order of magnitude better than current ex vivo CTC tests.
Who should consider this trial
Good fit: Adults 18–80 with histologically confirmed melanoma (Stages I–IV) who can sit still for 90 minutes are eligible, and healthy adult volunteers are also recruited for calibration.
Not a fit: Patients with active infection, significant comorbid medical or surgical conditions, organic brain syndrome, pregnant or breastfeeding women, or those unable to remain still for the required scan time are excluded and may not benefit from participation.
Why it matters
Potential benefit: If successful, the device could enable more sensitive, noninvasive detection and monitoring of melanoma spread from a simple bedside scan.
How similar studies have performed: Related photoacoustic and in vivo flow cytometry approaches have shown promising preclinical and small pilot results, but real-time in vivo detection of melanoma CTCs in larger clinical groups remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 80 years * Histological documented diagnosis of melanoma * Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB) * Must be able to sit still for 90 minutes Exclusion Criteria: * Active infection * Current and significant medical or surgical condition as determined by the Investigator * Diagnosis or evidence of organic brain syndrome * Pregnancy or breastfeeding
Where this trial is running
Little Rock, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Principal investigator: Jumin Sunde, MD — University of Arkansas
- Study coordinator: Jumin Sunde, MD
- Email: Jsunde2@uams.edu
- Phone: 501-526-6990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.