N/A
N=357
Hemangioma Associated With High Rates of Morbidity
Hemangioma
Bottom Line
View on ClinicalTrials.gov: NCT00394888 ↗Enrolled (actual)
357
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: MRI/MRA of Head/Neck/Chest. — 357 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRI (Device); MRI of head and neck (Device); Dermatological Examination (Other); Cardiac examination (Other); Abdominal ultrasound (Device)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MRI/MRA of Head/Neck/Chest. |
357 | — |
| PRIMARY Clinical Diagnosis of PHACE Syndrome |
33 | — |
| PRIMARY Spinal Abnormalities |
21 | — |
| PRIMARY Cerebrovascular and Structural Brain Abnormalities |
31 | — |
| PRIMARY Cardiac Abnormalities Detected Via Clinical Examination |
22 | — |
| PRIMARY Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound |
24 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00394888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.