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Feasibility and Functionality of fPAM Imaging in Melanoma

This study is currently recruiting participants.
Verified August 2011 by Washington University School of Medicine
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00776945
First received: October 20, 2008
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition
Melanoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Characterization and Early Diagnosis of Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Stage I - III melanoma.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with melanomas < 1mm.
  • Pregnant females.
  • Children and young adults < 18 yrs of age and patients who are unable to give informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776945

Contacts
Contact: Lynn A Cornelius, MD 314-362-8187 cornelil@wustl.edu
Contact: Mary Tabacchi 314-362-8171 mtabacch@dom.wustl.edu

Locations
United States, Missouri
Washington University and Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Mary Tabachhi     314-362-8171        
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Lynn A Cornelius, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Lynn A Cornelius, Washington University
ClinicalTrials.gov Identifier: NCT00776945     History of Changes
Other Study ID Numbers: 07-0635
Study First Received: October 20, 2008
Last Updated: August 16, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 16, 2013