Hemangioma Clinical Trial
Official title:
Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis
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.
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.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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