In Vivo Real-time Detection of Circulating Melanoma Cells

NCT01776905 | Recruiting

• 1 other identifier: 133965
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

Melanoma; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants that possess circulating tumor cells.

  14-21 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Expect to consent approximately 80 subjects in order to achieve an enrollment goal of 75 subjects at this institution in three cohorts.

You may qualify if:

• 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

You may not qualify if:

• Active infection
• Current and significant medical or surgical condition as determined by the Investigator
• Diagnosis or evidence of organic brain syndrome
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

MeSH Terms

Conditions

Melanoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jumin Sunde, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jumin Sunde, MD

CONTACT

501-526-6990; Jsunde2@uams.edu

Daniel Dunham

CONTACT

5016868274; ddunham@uams.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 28, 2013
• Study Start: February 1, 2013
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)