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Hemangioma Associated With High Rates of Morbidity

NCT ID: NCT00394888

Last Updated: 2013-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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 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.

Conditions

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Hemangioma

Keywords

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Hemangioma PHACE Lumbosacral hemangioma Occult Spinal Dysraphism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Facial Hemangioma

Patients with large facial hemangioma.

Group Type OTHER

MRI of head and neck

Intervention Type DEVICE

MRI of head and C-spine

Dermatological Examination

Intervention Type OTHER

Complete dermatological examination to identify and characterize nature of dermatological anomalies

Cardiac examination

Intervention Type OTHER

Complete cardiac examination

Lumbosacral Hemangioma

Patients with lumbosacral hemangioma.

Group Type OTHER

MRI

Intervention Type DEVICE

MRI of the spine.

Dermatological Examination

Intervention Type OTHER

Complete dermatological examination to identify and characterize nature of dermatological anomalies

Multiple Hemangiomas

patients with multiple hemangiomas (\>5)

Group Type OTHER

MRI

Intervention Type DEVICE

MRI of the spine.

Dermatological Examination

Intervention Type OTHER

Complete dermatological examination to identify and characterize nature of dermatological anomalies

Abdominal ultrasound

Intervention Type DEVICE

Abdominal ultrasound to detect hepatic hemangiomas

Interventions

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MRI

MRI of the spine.

Intervention Type DEVICE

MRI of head and neck

MRI of head and C-spine

Intervention Type DEVICE

Dermatological Examination

Complete dermatological examination to identify and characterize nature of dermatological anomalies

Intervention Type OTHER

Cardiac examination

Complete cardiac examination

Intervention Type OTHER

Abdominal ultrasound

Abdominal ultrasound to detect hepatic hemangiomas

Intervention Type DEVICE

Other Intervention Names

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Clinical dermatological examination Cardiovascular examination

Eligibility Criteria

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Inclusion Criteria

* Infants less than 1 year of age
* Hemangiomas of the head /facial area measuring 22cm2 or greater.


* 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

* 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


* Excluding perirectal hemangiomas that do not extend onto the sacral spine.
* Excluding perineal hemangiomas that do extend to overlay the sacral spine.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Beth Drolet

Professor and Vice Chair of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beth Drolet, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Maria Garzon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Denise Metry, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Ilona Frieden, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Julie Powell, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Sainte-Justine

Anne Lucky, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Cincinnati

Sharon Glick, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Downstate Medical Center

Eulalia Baselga, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Anita Haggstrom, M.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Anthony Mancini, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Kimberly Horii, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

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Beth Drolet, MD

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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High Risk Hemangioma

Identifier Type: -

Identifier Source: org_study_id