Diagnosis of Hemangiomas and Vascular Malformations

This study is enrolling participants by invitation only.

First Received: December 18, 2007 Last Updated: June 17, 2009 History of Changes

Sponsor:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00577213

Purpose

To develop a non-invasive, simple and affordable, measurement technique to differentiate hemangiomas from subtypes of VMS. The purpose of this study is to determine the best office based diagnositc instrument for differentiating the subtype of vascular lesions. The instrument must be simple and affordable so it can be used by primary car physicians in the doctor office. The procedure will be based on non-invasive and unharmful measurements that will be compared to the diagnosis from specialized physicians in this field and the final pathology.

Condition
Hemangiomas Vascular Malformations Venular Malformations Venous Malformations Lymphatic Malformations Arteriovenous Malformations

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Diagnosis of Hemangiomas and Vascular Malformations Using Non-Invasive Imaging Devices

Resource links provided by NLM:

MedlinePlus related topics: Arteriovenous Malformations

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	55
Study Start Date:	February 2007
Estimated Study Completion Date:	September 2010

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects with vascular lesions from the patient populations at Arkansas Children's Hospital (ACH) and the University of Arkansas for Medical Sciences (UAMS) will be recruited for the study. Approximately 45 subjects from Arkansas Children's Hospital and approximately 10 subjects from the University of Arkansas for Medical Sciences will be recruited for a total of 55.

Criteria

Inclusion Criteria:

Suspected Hemangioma, Vascular Malformations (VMS) including venular Malformations (port-wine stain, PWS), Venous Malformations, Lymphatic Malformations, Arteriovenous Malformations or mixed malformations.

Exclusion Criteria:

All pregnant individuals will be excluded, since physiologic changes of pregnancy could alter characteristics of the vascular lesion.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577213

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:	Gal Shafirstein, Ph.D.	UAMS, ACH, Central Arkansas Veterans Healthcare System
Study Director:	Jessica L Blackwell	UAMS, ACH, Central Arkansas Veterans Healthcare System

More Information

No publications provided

Responsible Party:	University of Arkansas, Arkansas Children's Hospital ( Dr. Gal Shafirstein )
Study ID Numbers:	47573, Chancellor's Fund
Study First Received:	December 18, 2007
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00577213 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

Diagnosis
Hemangiomas
Vascular Malformations
Venular Malformations

Venous Malformations
Lymphatic Malformations
Arteriovenous Malformations

Additional relevant MeSH terms:

Lymphatic Abnormalities
Neoplasms by Histologic Type
Aneurysm
Cardiovascular Abnormalities
Vascular Diseases
Lymphatic Diseases
Neoplasms

Vascular Malformations
Hemangioma
Neoplasms, Vascular Tissue
Arteriovenous Malformations
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 27, 2009