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Completed

NCT Number: NCT00394888

Hemangioma Associated With High Rates of Morbidity

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Drolet, MD

Milwaukee, Wisconsin, 53226, United States

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Device

MRI of the spine.

MRI of head and neck

Device

MRI of head and C-spine

Dermatological Examination

Other

Complete dermatological examination to identify and characterize nature of dermatological anomalies

Other names: Clinical dermatological examination

Cardiac examination

Other

Complete cardiac examination

Other names: Cardiovascular examination

Abdominal Ultrasound

Device

Abdominal ultrasound to detect hepatic hemangiomas

Primary outcomes

  1. MRI/MRA of Head/Neck/Chest.

    Time frame: 2 years

  2. 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.

  3. Spinal Abnormalities

    Time frame: 2 years

    The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Baylor College of Medicine
  • Children's Hospital Medical Center, Cincinnati
  • Children's Mercy Hospital Kansas City
  • Columbia University
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • St. Justine's Hospital
  • State University of New York - Downstate Medical Center
  • University of California, San Francisco

Registry information

Official study title

Hemangioma Associated With High Rates of Morbidity:A Prospective Study

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Nov 2, 2006
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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