- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265902
Infrared Thermography in Finding Skin Lesions in Patients With Kaposi's Sarcoma
Ultra-Sensitive, Infra-Red Thermographic Analysis of Kaposi's Sarcoma Skin Lesions
RATIONALE: Diagnostic procedures, such as infrared thermography, may help find Kaposi's sarcoma and learn the extent of disease.
PURPOSE: This clinical trial is studying how well infrared thermography finds skin lesions in patients with Kaposi's sarcoma.
Study Overview
Detailed Description
OBJECTIVES:
Primary
- Compare ultra-sensitive infrared thermographic images with visible light digital photographic images and clinical dermatologic examination as methods of measuring cutaneous lesions in patients with Kaposi's sarcoma (KS).
Secondary
- Compare differences in modulation of temperature detected in KS skin lesions with non-involved skin of the same patient and with normal skin of healthy volunteers by sequential imaging using the infrared thermographic camera.
OUTLINE: This is a controlled, pilot study.
Patients undergo clinical assessment followed by simultaneous digital photographic camera imaging and high-resolution infrared thermographic camera imaging of designated normal skin areas and selected marker lesions. Before imaging, a metal bar chilled to 0º C, 10º C, and 25º C is applied to the lesions and designated normal skin areas for up to 90 seconds.
Healthy volunteers (controls) undergo the same procedure as for the patient except only designated normal skin areas are used.
PROJECTED ACCRUAL: A total of 20 patients and 10 healthy volunteers (controls) will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Histologically confirmed cutaneous Kaposi's sarcoma (KS)
- At least one skin lesion accessible for imaging
- HIV positivity with proven cutaneous KS and concurrent visceral or mucous membrane involvement allowed
- Healthy volunteer (regardless of HIV status) (control)
PATIENT CHARACTERISTICS:
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Pregnancy allowed
PRIOR CONCURRENT THERAPY:
- Prior topical, intralesional, or systemic treatment allowed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Ciro Martins, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- J0429
- CDR0000452799 (Registry Identifier: PDQ (Physician Data Query))
- JHOC-0429
- 04-08-06-02 (Other Identifier: JHM IRB)
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