In Vivo Real-time Detection of Circulating Melanoma Cells
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• 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
Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
Contact Information
Primary
Jumin Sunde, MD
Jsunde2@uams.edu
501-526-6990
Backup
Daniel Dunham
ddunham@uams.edu
5016868274
Time Frame
Start Date: 2013-02
Estimated Completion Date: 2026-07
Participants
Target number of participants: 75
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Arkansas