Recruiting

Photoacoustic Flow Cytometry

Sponsor:

University of Arkansas

Code:

NCT01776905

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Melanoma

Study ID

NCT01776905

Start date

Feb, 2013

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of participants that possess circulating tumor cells. [ Time Frame: 14-21 days ]

Central Contacts and Locations

Central contacts

Jumin Sunde, MD

501-526-6990Jsunde2@uams.edu

Daniel Dunham

5016868274ddunham@uams.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Jumin Sunde, MD

501-603-1214JSunde2@uams.edu

Principal Investigator:

Jumin Sunde

More Information

Sponsor

University of Arkansas

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Melanoma
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-06-17.