Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

• ClinicalTrials.gov Identifier: NCT00374335
• Recruitment Status: Completed
• First Posted: September 11, 2006
• Results First Posted: September 12, 2011
• Last Update Posted: September 16, 2011
• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: Medical College of Wisconsin; University of California, San Francisco; Columbia University; Baylor College of Medicine; Northwestern University; St. Justine's Hospital; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Information provided by (Responsible Party): Children's Mercy Hospital Kansas City

Study Description

Brief Summary:

This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.

Condition or disease	Intervention/treatment	Phase
Hemangioma	Procedure: abdominal ultrasound; Other: Dermatologic Examination	Not Applicable

Detailed Description:

Hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. While most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. In addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. Certain "high risk" hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. The true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis.

One of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma >30 cm2 versus imaging results in patients without cutaneous hemangiomas. The study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 261 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis
• Study Start Date: September 2006
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
infants with cutaneous hemangiomas	Procedure: abdominal ultrasound; abdominal ultrasound to detect hepatic hemangiomas; Other: Dermatologic Examination; Complete dermatologic examination

Outcome Measures

Primary Outcome Measures :

1. Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound [ Time Frame: 2 years ]
   The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound
2. Presence of Hepatic Hemangiomas on Abdominal Ultrasound [ Time Frame: 2 years ]
   The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound

Secondary Outcome Measures :

1. Risk Factors Associated With the Development of Hepatic Hemangiomas [ Time Frame: 2 years ]
   Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound

Eligibility Criteria

• Ages Eligible for Study: up to 6 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Infants less than 6 months of age
• clinical diagnosis of 1-4 cutaneous hemangiomas
• clinical diagnosis of 5 or more cutaneous hemangiomas
• clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2

Exclusion Criteria:

• Infants greater than 6 months of age

Contacts and Locations

Locations

United States, Missouri

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Medical College of Wisconsin

University of California, San Francisco

Columbia University

Baylor College of Medicine

Northwestern University

St. Justine's Hospital

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

• Principal Investigator: Beth A Drolet, MD; Medical College of Wisconsin
• Principal Investigator: Maria Garzon, MD; Columbia University
• Principal Investigator: Kimberly A Horii, MD; Children's Mercy Hospital Kansas City
• Principal Investigator: Denise Metry, MD; Baylor College of Medicine
• Principal Investigator: Sarah Chamlin, MD; Northwestern University-Children's Memorial Hospital
• Principal Investigator: Ilona J Frieden, MD; University of California, San Francisco
• Principal Investigator: Julie Powell, MD; St. Justine's Hospital
• Principal Investigator: Anne Lucky, MD; Children's Hospital of Cincinnati
• Principal Investigator: Eulalia Baselga, MD; Hospital de la Santa Crue i Santa Pau

More Information

Publications:

Chiller KG, Passaro D, Frieden IJ. Hemangiomas of infancy: clinical characteristics, morphologic subtypes, and their relationship to race, ethnicity, and sex. Arch Dermatol. 2002 Dec;138(12):1567-76.

Boon LM, Burrows PE, Paltiel HJ, Lund DP, Ezekowitz RA, Folkman J, Mulliken JB. Hepatic vascular anomalies in infancy: a twenty-seven-year experience. J Pediatr. 1996 Sep;129(3):346-54. Review.

Metry DW, Hawrot A, Altman C, Frieden IJ. Association of solitary, segmental hemangiomas of the skin with visceral hemangiomatosis. Arch Dermatol. 2004 May;140(5):591-6. Review.

Hughes JA, Hill V, Patel K, Syed S, Harper J, De Bruyn R. Cutaneous haemangioma: prevalence and sonographic characteristics of associated hepatic haemangioma. Clin Radiol. 2004 Mar;59(3):273-80.

Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003 Apr;48(4):477-93; quiz 494-6. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Horii KA, Drolet BA, Baselga E, Frieden IJ, Metry DW, Morel KD, Newell BD, Nopper AJ, Garzon MC; Hemangioma Investigator Group. Risk of hepatic hemangiomas in infants with large hemangiomas. Arch Dermatol. 2010 Feb;146(2):201-3. doi: 10.1001/archdermatol.2009.391.

• Responsible Party: Children's Mercy Hospital Kansas City
• ClinicalTrials.gov Identifier: NCT00374335
• Other Study ID Numbers: 06 02 029E
• First Posted: September 11, 2006
• Results First Posted: September 12, 2011
• Last Update Posted: September 16, 2011
• Last Verified: September 2011

Keywords provided by Children's Mercy Hospital Kansas City:

prospective cohort study

Additional relevant MeSH terms:

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms