Hemangioma Associated With High Rates of Morbidity
Hemangioma Associated With High Rates of Morbidity:A Prospective Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Beth Drolet, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Facial Hemangioma
Patients with large facial hemangioma.
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MRI of head and C-spine
Complete dermatological examination to identify and characterize nature of dermatological anomalies
Other Names:
Complete cardiac examination
Other Names:
|
|
Other: Lumbosacral Hemangioma
Patients with lumbosacral hemangioma.
|
Complete dermatological examination to identify and characterize nature of dermatological anomalies
Other Names:
MRI of the spine.
|
|
Other: Multiple Hemangiomas
patients with multiple hemangiomas (>5)
|
Complete dermatological examination to identify and characterize nature of dermatological anomalies
Other Names:
MRI of the spine.
Abdominal ultrasound to detect hepatic hemangiomas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MRI/MRA of Head/Neck/Chest.
Time Frame: 2 years
|
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.
|
2 years
|
|
Spinal Abnormalities
Time Frame: 2 years
|
The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.
|
2 years
|
|
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.
|
2 years
|
|
Cardiac Abnormalities Detected Via Clinical Examination
Time Frame: 2 years
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The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.
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2 years
|
|
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.
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2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- High Risk Hemangioma
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