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| 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 |
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| Information provided by: | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00394888 |
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 |
| Study Type: | Interventional |
| Study Design: | Screening, Non-Randomized, Open Label, Active Control, Single Group Assignment |
| Official Title: | Hemangioma Associated With High Rates of Morbidity:A Prospective Study |
| Estimated Enrollment: | 280 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Patients with large facial hemangioma.
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Device: MRI
MRI of the head/face/ches
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2
Patients with lumbosacral hemangioma.
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Device: MRI
MRI of the spine.
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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 cm2) 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 (> 2.5cm 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 |
Segmental Facial Hemangioma
Inclusion criteria:
Exclusion criteria:
Lumbosacral Hemangioma
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| Beth Drolet, MD | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Amy E Heinrich, RN, 414-456-5769 aheinric@mcw.edu | |
| Contact: Beth Drolet, MD 414-266-1569 bdrolet@mcw.edu | |
| 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
| Responsible Party: | Medical College of Wisconsin ( Beth Drolet, MD ) |
| Study ID Numbers: | High Risk Hemangioma |
| Study First Received: | November 1, 2006 |
| Last Updated: | December 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00394888 |
| Health Authority: | United States: Institutional Review Board |
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Hemangioma PHACE Lumbosacral hemangioma Occult Spinal Dysraphism |
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Spinal Dysraphism Spina bifida Hemangioma |
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Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue |
