Hemangioma Associated With High Rates of Morbidity

Medical College of Wisconsin

Status: Completed

Conditions: Hemangioma

Treatments: Device: MRI of head and neck; Other: Dermatological Examination; Device: Abdominal ultrasound; Other: Cardiac examination; Device: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT00394888

High Risk Hemangioma

Details and patient eligibility

About

We are conducting a study on the possible presence of PHACES in children with large facial hemangiomas and lumbosacral hemangiomas of infancy (hemangioma in the lower back) . With this study we hope to better understand the risk of this syndrome and to develop guidelines for its evaluation and management.

Full description

Large hemangiomas of the face can be associated with anomalies of the blood vessels of head and chest. The acronym PHACES indicates the association of Posterior fossa and other brain malformations, facial Hemangioma, Arterial anomalies, Coarctation of the aorta and other cardiac defects, Eye abnormalities and Sternal malformations. Study subjects will be recruited through the Pediatric Dermatology department in several cities. All patients age 0-1 year old of age, who present with large facial hemangioma (>22 cm^2) will be offered to participate in the study. Parents will be interviewed to obtain personal, medical, and family history.

Patients will undergo standard of care evaluation for facial hemangioma with risk of PHACE syndrome. This includes skin, eye and neurological examination, photograph, magnetic resonance imaging (MRI) of head/neck/chest, and lab tests requiring samples of blood, urine or stool. No other tests will be performed for participating in the study.

Lumbosacral hemangiomas of infancy (hemangioma in the lower back) can be associated with anomalies of the spine. "Tethered cord syndrome" indicates a condition caused by abnormally stretched spinal cord. Over time this condition can lead to neurological damage. Although often there are no symptoms until adulthood, it can become apparent during childhood. Common symptoms are: lower back pain, pain and weakness of the legs, walking problems, and bladder and bowel loss of control. "Occult spinal dysraphism" is the term used when the defect of the spine is hidden under normal skin. We noticed that infants with hemangioma in the lower back area are more inclined to present a hidden spine defect.

Study subjects will be recruited through the Pediatric Dermatology departments in several cities. All patients age 0-18 year old of age, who present with lumbosacral hemangioma (> 2.5 cm of diameter overlying the spine) will be offered to participate in the study. Parents will be interviewed to obtain personal, medical, and family history.

Patients will undergo standard of care evaluation for lumbosacral hemangioma. This includes skin, neurological examination, photograph, magnetic resonance imaging (MRI) of the back, lab tests requiring samples of blood, urine or stool. No additional tests will be performed only for participating in the study.

Enrollment: 433 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Segmental Facial Hemangioma

Inclusion criteria:

• Infants less than 1 year of age
• Hemangiomas of the head /facial area measuring 22cm2 or greater.

Exclusion criteria:

• Children greater than 1 year of age.
• Children with segmental hemangiomas present in locations other than the head.
• Children presenting with localized (focal) or indeterminate hemangiomas in any location.
• Children with other vascular tumors (such as tufted angioma, Kaposiform hemangioendothelioma, non-involuting congenital hemangioma or rapidly-involuting congenital hemangioma) or vascular malformations.

Lumbosacral Hemangioma

Inclusion criteria:

• Individuals less than 18 years of age.
• Hemangioma, hemangioma precursor, or definitive residual hemangioma larger then 2.5 cm in diameter, overlying the midline lumbar spine or sacral spine in which any portion of the hemangioma is located over the midline.

Exclusion Criteria:

• Excluding perirectal hemangiomas that do not extend onto the sacral spine.
• Excluding perineal hemangiomas that do extend to overlay the sacral spine.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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433 participants in 3 patient groups

Facial Hemangioma

Other group

Description:

Patients with large facial hemangioma.

Treatment:

Other: Cardiac examination

Device: MRI of head and neck

Other: Dermatological Examination

Lumbosacral Hemangioma

Other group

Description:

Patients with lumbosacral hemangioma.

Treatment:

Device: MRI

Other: Dermatological Examination

Multiple Hemangiomas

Other group

Description:

patients with multiple hemangiomas (\>5)

Treatment:

Device: Abdominal ultrasound

Device: MRI

Other: Dermatological Examination