Infrared Thermography in Finding Skin Lesions in Patients... | NCT00265902

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

NCT00265902

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Terminated

Last Update Posted

Mar 20, 2019Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Sarcoma

Interventions

diagnostic imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
CDR0000452799	Registry Identifier	PDQ (Physician Data Query)
JHOC-0429
04-08-06-02	Other Identifier	JHM IRB

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low accrual

Expanded Access Info

Start Date

Oct 3, 2005Actual

Primary Completion Date

Mar 21, 2006Actual

Completion Date

Mar 21, 2006Actual

First Submitted Date

Dec 14, 2005

First Submission Date that Met QC Criteria

Dec 14, 2005

First Posted Date

Dec 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2019

Last Update Posted Date

Mar 20, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Name	Type	Description	Arm Group Labels	Other Names
diagnostic imaging	Procedure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ciro Martins, MD	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins		Baltimore	Maryland	21231-2410	United States

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma
D012514	Sarcoma, Kaposi

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006566	Herpesviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided