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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00265902
Other study ID # J0429
Secondary ID CDR0000452799JHO
Status Terminated
Phase N/A
First received
Last updated
Start date October 3, 2005
Est. completion date March 21, 2006

Study information

Verified date June 2006
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date March 21, 2006
Est. primary completion date March 21, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
diagnostic imaging


Locations

Country Name City State
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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