Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Vladimir Zharov, PhD
501-603-1213
ZharovVladimirP@uams.edu

More Details

NCT ID
NCT01776905
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

Issam Makhoul, MD
501-526-6990
MakhoulIssam@uams.edu

Detailed Description

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:

1. Cohort #1 will consist of fifteen healthy control subjects, ten of whom will be Caucasian and five of whom will be African-American. Subjects in cohort #1 will be used to address the calibration goal of Specific Aim #1.

2. Cohort #2 will consist of 30 subjects who have advanced-stage melanoma will be recruited from the Medical Oncology clinic at UAMS, where advanced stages are defined as Stages III or IV. Subjects in cohort #2 will be used to address the validation goal of Specific Aim #2. Approximately half of the 30 advanced-stage subjects will be Stage III and the other half will be Stage IV.

3. Cohort #3 will consist of 30 subjects with early-stage melanoma will be recruited from the Surgical Oncology clinic at UAMS, where early stages are defined as Stages I or II.

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.