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Hemangioma Associated With High Rates of Morbidity:A Prospective Study


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18 Years
Not Enrolling
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Hemangioma

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Trial Information

Hemangioma Associated With High Rates of Morbidity:A Prospective Study


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

MRI/MRA of Head/Neck/Chest.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Beth Drolet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Institutional Review Board

Study ID:

High Risk Hemangioma

NCT ID:

NCT00394888

Start Date:

November 2005

Completion Date:

January 2010

Related Keywords:

  • Hemangioma
  • Hemangioma
  • PHACE
  • Lumbosacral hemangioma
  • Occult Spinal Dysraphism
  • Hemangioma

Name

Location

Beth Drolet, MD Milwaukee, Wisconsin  53226