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Infrared Thermography in Finding Skin Lesions in Patients With Kaposi's Sarcoma

Primary Purpose

Sarcoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diagnostic imaging
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoma focused on measuring Kaposi sarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 14, 2005
Last Updated
March 18, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00265902
Brief Title
Infrared Thermography in Finding Skin Lesions in Patients With Kaposi's Sarcoma
Official Title
Ultra-Sensitive, Infra-Red Thermographic Analysis of Kaposi's Sarcoma Skin Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
October 3, 2005 (Actual)
Primary Completion Date
March 21, 2006 (Actual)
Study Completion Date
March 21, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Kaposi sarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
diagnostic imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ciro Martins, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

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Infrared Thermography in Finding Skin Lesions in Patients With Kaposi's Sarcoma

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