Hemangioma Associated With High Rates of Morbidity

Hemangioma Clinical Trial

Official title:

Hemangioma Associated With High Rates of Morbidity:A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394888
• Other study ID #: High Risk Hemangioma
• Status: Completed
• Phase: N/A
• First received: November 1, 2006
• Last updated: September 17, 2013
• Start date: November 2005
• Est. completion date: January 2010

Study information

• Verified date: September 2013
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Hemangioma

Intervention

Device:
• MRI
MRI of the spine.
• 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
• Cardiac examination
Complete cardiac examination

Device:
• Abdominal ultrasound
Abdominal ultrasound to detect hepatic hemangiomas

Locations

Country	Name	City	State
United States	Beth Drolet, MD	Milwaukee	Wisconsin

Sponsors (9)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Baylor College of Medicine, Children's Hospital Medical Center, Cincinnati, Children's Mercy Hospital Kansas City, Columbia University, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, St. Justine's Hospital, State University of New York - Downstate Medical Center, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI/MRA of Head/Neck/Chest.		2 years	No
Primary	Clinical Diagnosis of PHACE Syndrome	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	No
Primary	Spinal Abnormalities	The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.	2 years	No
Primary	Cerebrovascular and Structural Brain Abnormalities	The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.	2 years	Yes
Primary	Cardiac Abnormalities Detected Via Clinical Examination	The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.	2 years	No
Primary	Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound	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.	2 years	No