Feasibility and Functionality of fPAM Imaging in Melanoma

Melanoma Clinical Trial

— fPAM  

Official title:

Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Characterization and Early Diagnosis of Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00776945
• Other study ID #: 07-0635
• Status: Terminated
• Phase: N/A
• First received: October 20, 2008
• Last updated: June 5, 2015
• Start date: January 2009
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No