NCT00394888

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 6, 2011

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

4 years

First QC Date

November 1, 2006

Results QC Date

May 4, 2011

Last Update Submit

September 17, 2013

Conditions

Hemangioma

Keywords

HemangiomaPHACELumbosacral hemangiomaOccult Spinal Dysraphism

Outcome Measures

Primary Outcomes (6)

  • MRI/MRA of Head/Neck/Chest.

    2 years

  • 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

  • Spinal Abnormalities

    The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.

    2 years

  • Cerebrovascular and Structural Brain Abnormalities

    The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.

    2 years

  • 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

  • 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

Study Arms (3)

Facial Hemangioma

OTHER

Patients with large facial hemangioma.

Device: MRI of head and neckOther: Dermatological ExaminationOther: Cardiac examination

Lumbosacral Hemangioma

OTHER

Patients with lumbosacral hemangioma.

Device: MRIOther: Dermatological Examination

Multiple Hemangiomas

OTHER

patients with multiple hemangiomas (\>5)

Device: MRIOther: Dermatological ExaminationDevice: Abdominal ultrasound

Interventions

MRIDEVICE

MRI of the spine.

Lumbosacral HemangiomaMultiple Hemangiomas
MRI of head and neckDEVICE

MRI of head and C-spine

Facial Hemangioma
Dermatological ExaminationOTHER

Complete dermatological examination to identify and characterize nature of dermatological anomalies

Also known as: Clinical dermatological examination
Facial HemangiomaLumbosacral HemangiomaMultiple Hemangiomas
Cardiac examinationOTHER

Complete cardiac examination

Also known as: Cardiovascular examination
Facial Hemangioma
Abdominal ultrasoundDEVICE

Abdominal ultrasound to detect hepatic hemangiomas

Multiple Hemangiomas

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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.
  • Excluding perirectal hemangiomas that do not extend onto the sacral spine.
  • Excluding perineal hemangiomas that do extend to overlay the sacral spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Drolet, MD

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

HemangiomaNeural Tube Defects

Condition Hierarchy (Ancestors)

Neoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Dr. Beth Drolet
Organization
Medical College of Wisconsin
bdrolet@mcw.edu
414-266-1569

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair of Dermatology

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

November 1, 2005

Primary Completion

November 1, 2009

Study Completion

January 1, 2010

Last Updated

September 20, 2013

Results First Posted

July 6, 2011

Record last verified: 2013-09

Locations

US(1)