Clinical Trial: Hemangioma Associated With High Rates of Morbidity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Hemangioma Associated With High Rates of Morbidity:A Prospective Study

Brief Summary: 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.

Detailed Summary:

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 citie
Sponsor: Medical College of Wisconsin

Current Primary Outcome:

  • MRI/MRA of Head/Neck/Chest. [ Time Frame: 2 years ]
  • Clinical Diagnosis of PHACE Syndrome [ Time Frame: 2 years ]
    For subjects in the large facial hemangioma arm of the study, a clinical assessment by trained physicians was conducted to determine whether or not each subject met diagnostic criteria for PHACE syndrome.
  • Spinal Abnormalities [ Time Frame: 2 years ]
    The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.
  • Cerebrovascular and Structural Brain Abnormalities [ Time Frame: 2 years ]
    The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.
  • Cardiac Abnormalities Detected Via Clinical Examination [ Time Frame: 2 years ]
    The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.
  • Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound [ Time Frame: 2 years ]
    The number of participants with multiple (greater than or equal to 5) cutaneous infantile hemangiomas who were found to have hepatic hemangiomas via the us abdominal ultrasound.


Original Primary Outcome:

  • The presence of hemangiomas associated with PHACES using MRI/MRA of head/neck/chest.
  • The presence of hemangiomas associated with spinal dysraphism using ultrasound or MRI of the spine.


Current Secondary Outcome:

Original Secondary Outcome:

  • Identify risk factors of facial segmental hemangiomas using systematic collection and analysis of clinical and radiologic features.
  • Identify risk factors of lumbosacral hemangioma associated with spinal dysraphism using systematic collection and analysis of clinical and radiologic features.


Information By: Medical College of Wisconsin

Dates:
Date Received: November 1, 2006
Date Started: November 2005
Date Completion:
Last Updated: September 17, 2013
Last Verified: September 2013