Feasibility and Functionality of fPAM Imaging in Melanoma

This study has been terminated.
(no funding)
Sponsor:
Information provided by (Responsible Party):
Lynn Cornelius, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00776945
First received: October 20, 2008
Last updated: November 26, 2013
Last verified: November 2013
  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:


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

Primary Outcome Measures:
  • fPAM is a hybrid imaging technique that detects absorbed diffuse photons ultrasonically through the photoacoustic (PA) effect [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Evaluate pigmented lesions for depth, width, total hemoglobin saturation, melanin distribution, and melanin concentration using fPAM in vivo and ex vivo


Biospecimen Retention:   Samples Without DNA

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


Enrollment: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776945

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Washington University
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Lynn A Cornelius, MD Washington University Early Recognition Center
  More Information

No publications provided

Responsible Party: Lynn Cornelius, MD, Chief, Division of Dermatology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00776945     History of Changes
Other Study ID Numbers: 07-0635
Study First Received: October 20, 2008
Last Updated: November 26, 2013
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 September 30, 2014