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Diagnosis of Hemangiomas and Vascular Malformations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00577213
First received: December 18, 2007
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  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: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Diagnosis of Hemangiomas and Vascular Malformations Using Non-invasive Imaging Devices

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Enrollment: 56
Study Start Date: February 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  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 Boswell UAMS, ACH, Central Arkansas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00577213     History of Changes
Other Study ID Numbers: 47573, Chancellor's Fund
Study First Received: December 18, 2007
Last Updated: October 25, 2012
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:
Congenital Abnormalities
Arteriovenous Malformations
Aneurysm
Hemangioma
Vascular Malformations
Lymphatic Abnormalities
Cardiovascular Abnormalities
 Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013