Feasibility and Functionality of fPAM Imaging in Melanoma

NCT00776945 | Terminated

• 1 other identifier: 07-0635
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• fPAM is a hybrid imaging technique that detects absorbed diffuse photons ultrasonically through the photoacoustic (PA) effect

  Evaluate pigmented lesions for depth, width, total hemoglobin saturation, melanin distribution, and melanin concentration using fPAM in vivo and ex vivo

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Stage I - III melanoma.

You may qualify if:

• Adult patients (\> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent.

You may not qualify if:

• Patients with melanomas \< 1mm.
• Pregnant females.
• Children and young adults \< 18 yrs of age and patients who are unable to give informed consent.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue biopsies may be performed if locoregional recurrence validated by clinical examination.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Lynn A Cornelius, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Dermatology

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 22, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2013-11

Locations

US (2)