Feasibility and Functionality of fPAM Imaging in Melanoma (fPAM)

• ClinicalTrials.gov Identifier: NCT00776945
• Recruitment Status: Terminated
• First Posted: October 22, 2008
• Last Update Posted: June 8, 2015
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Lynn Cornelius, MD, Washington University School of Medicine

Tracking Information

• First Submitted Date: October 20, 2008
• First Posted Date: October 22, 2008
• Last Update Posted Date: June 8, 2015
• Study Start Date: January 2009
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 26, 2013)

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

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Feasibility and Functionality of fPAM Imaging in Melanoma
• Official Title: Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Characterization and Early Diagnosis of Melanoma
• 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.
• Detailed Description: recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

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

• Sampling Method: Non-Probability Sample
• Study Population: Patients with Stage I - III melanoma.
• Condition: Melanoma
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 26, 2013): 2
• Original Estimated Enrollment (submitted: October 21, 2008): 200
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00776945
• Other Study ID Numbers: 07-0635
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lynn Cornelius, MD, Washington University School of Medicine
• Study Sponsor: Washington University School of Medicine
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lynn A Cornelius, MD; Washington University School of Medicine

• PRS Account: Washington University School of Medicine
• Verification Date: November 2013