Hemangioma Associated With High Rates of Morbidity

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Columbia University
Baylor College of Medicine
Hospital St. Justine
State University of New York - Downstate Medical Center
Children's Mercy Hospital Kansas City
Children's Hospital Medical Center, Cincinnati
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00394888
First received: November 1, 2006
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Hemangioma
Device: MRI
Device: MRI of head and neck
Other: Dermatological Examination
Other: Cardiac examination
Device: Abdominal ultrasound

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Hemangioma Associated With High Rates of Morbidity:A Prospective Study

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • MRI/MRA of Head/Neck/Chest. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical Diagnosis of PHACE Syndrome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.

  • Cerebrovascular and Structural Brain Abnormalities [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 433
Study Start Date: November 2005
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Facial Hemangioma
Patients with large facial hemangioma.
Device: MRI of head and neck
MRI of head and C-spine
Other: Dermatological Examination
Complete dermatological examination to identify and characterize nature of dermatological anomalies
Other Name: Clinical dermatological examination
Other: Cardiac examination
Complete cardiac examination
Other Name: Cardiovascular examination
Lumbosacral Hemangioma
Patients with lumbosacral hemangioma.
Device: MRI
MRI of the spine.
Other: Dermatological Examination
Complete dermatological examination to identify and characterize nature of dermatological anomalies
Other Name: Clinical dermatological examination
Multiple Hemangiomas
patients with multiple hemangiomas (>5)
Device: MRI
MRI of the spine.
Other: Dermatological Examination
Complete dermatological examination to identify and characterize nature of dermatological anomalies
Other Name: Clinical dermatological examination
Device: Abdominal ultrasound
Abdominal ultrasound to detect hepatic hemangiomas

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394888

Locations
United States, Wisconsin
Beth Drolet, MD
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
University of California, San Francisco
Columbia University
Baylor College of Medicine
Hospital St. Justine
State University of New York - Downstate Medical Center
Children's Mercy Hospital Kansas City
Children's Hospital Medical Center, Cincinnati
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Beth Drolet, MD Medical College of Wisconsin
Principal Investigator: Maria Garzon, MD Columbia University
Principal Investigator: Denise Metry, MD Baylor College of Medicine
Principal Investigator: Ilona Frieden, MD University of California, San Francisco
Principal Investigator: Julie Powell, MD Hopital Sainte-Justine
Principal Investigator: Anne Lucky, MD Children's Hospital of Cincinnati
Principal Investigator: Sharon Glick, MD State University of New York - Downstate Medical Center
Principal Investigator: Eulalia Baselga, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator: Anita Haggstrom, M.D. Indiana University
Principal Investigator: Anthony Mancini, MD Northwestern University
Principal Investigator: Kimberly Horii, MD Children's Mercy Hospital Kansas City
  More Information

No publications provided

Responsible Party: Beth Drolet, Professor and Vice Chair of Dermatology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00394888     History of Changes
Other Study ID Numbers: High Risk Hemangioma
Study First Received: November 1, 2006
Results First Received: May 4, 2011
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Hemangioma
PHACE
Lumbosacral hemangioma
Occult Spinal Dysraphism

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014