Know Cancer

forgot password

Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis

6 Months
Not Enrolling

Thank you

Trial Information

Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Beth A Drolet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Institutional Review Board

Study ID:

06 02 029E



Start Date:

September 2006

Completion Date:

December 2009

Related Keywords:

  • Hemangioma
  • prospective cohort study
  • Hemangioma



Children's Mercy Hospital Kansas City, Missouri  64108