Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemangioma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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infants with cutaneous hemangiomas

Group Type OTHER

abdominal ultrasound

Intervention Type PROCEDURE

abdominal ultrasound to detect hepatic hemangiomas

Dermatologic Examination

Intervention Type OTHER

Complete dermatologic examination

Interventions

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abdominal ultrasound

abdominal ultrasound to detect hepatic hemangiomas

Intervention Type PROCEDURE

Dermatologic Examination

Complete dermatologic examination

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beth A Drolet, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Maria Garzon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Kimberly A Horii, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Denise Metry, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Sarah Chamlin, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University-Children's Memorial Hospital

Ilona J Frieden, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Julie Powell, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Anne Lucky, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Cincinnati

Eulalia Baselga, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de la Santa Crue i Santa Pau

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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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. doi: 10.1001/archderm.138.12.1567.

Reference Type BACKGROUND

PMID: 12472344 (View on PubMed)

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. doi: 10.1016/s0022-3476(96)70065-3.

Reference Type BACKGROUND

PMID: 8804322 (View on PubMed)

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. doi: 10.1001/archderm.140.5.591.

Reference Type BACKGROUND

PMID: 15148105 (View on PubMed)

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. doi: 10.1016/S0009-9260(03)00267-8.

Reference Type BACKGROUND

PMID: 15037141 (View on PubMed)

Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003 Apr;48(4):477-93; quiz 494-6. doi: 10.1067/mjd.2003.200.

Reference Type BACKGROUND

PMID: 12664009 (View on PubMed)

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. No abstract available.

Reference Type DERIVED

PMID: 20157038 (View on PubMed)

Other Identifiers

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06 02 029E

Identifier Type: -

Identifier Source: org_study_id

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Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

Hemangioma Associated With High Rates of Morbidity

Clinical Characteristics of Infantile Hemangioma

A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China

Optical Tomographic Imaging of Infantile Hemangiomas

Detailed Description

Conditions

Study Design

Study Groups

infants with cutaneous hemangiomas

abdominal ultrasound

Dermatologic Examination

Interventions

abdominal ultrasound

Dermatologic Examination

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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

Children's Mercy Hospital Kansas City

Responsible Party

Principal Investigators

Beth A Drolet, MD

Maria Garzon, MD

Kimberly A Horii, MD

Denise Metry, MD

Sarah Chamlin, MD

Ilona J Frieden, MD

Julie Powell, MD

Anne Lucky, MD

Eulalia Baselga, MD

Locations

Children's Mercy Hospital

Countries

References

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. doi: 10.1001/archderm.138.12.1567.

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. doi: 10.1016/s0022-3476(96)70065-3.

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. doi: 10.1001/archderm.140.5.591.

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. doi: 10.1016/S0009-9260(03)00267-8.

Bruckner AL, Frieden IJ. Hemangiomas of infancy. J Am Acad Dermatol. 2003 Apr;48(4):477-93; quiz 494-6. doi: 10.1067/mjd.2003.200.

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. No abstract available.

Other Identifiers

06 02 029E

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