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Feasibility and Functionality of fPAM Imaging in Melanoma (fPAM)
This study has been terminated.
(no funding)
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Lynn Cornelius, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00776945
First received: October 20, 2008
Last updated: June 5, 2015
Last verified: November 2013
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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 Lynn Cornelius, MD, 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 ]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 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00776945
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 School of Medicine |
More Information
| 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: | June 5, 2015 |
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 July 24, 2017