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Trial record 7 of 10 for:    Tethered Spinal Cord Syndrome

Hemangioma Associated With High Rates of Morbidity

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ClinicalTrials.gov Identifier: NCT00394888
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : July 6, 2011
Last Update Posted : September 20, 2013
Sponsor:
Collaborators:
University of California, San Francisco
Columbia University
Baylor College of Medicine
St. Justine's Hospital
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
Information provided by (Responsible Party):
Beth Drolet, Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Hemangioma
Interventions Device: MRI
Device: MRI of head and neck
Other: Dermatological Examination
Other: Cardiac examination
Device: Abdominal ultrasound
Enrollment 433
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Facial Hemangioma Lumbosacral Hemangioma Multiple Hemangiomas
Hide Arm/Group Description Patients with large facial hemangioma. Patients with lumbosacral hemangioma. Patients with multiple hemangiomas
Period Title: Overall Study
Started 108 48 201
Completed 108 48 201
Not Completed 0 0 0
Arm/Group Title Facial Hemangioma Lumbosacral Hemangioma Multiple Hemangiomas Total
Hide Arm/Group Description Patients with large facial hemangioma. Patients with lumbosacral hemangioma. Patients with multiple hemangiomas Total of all reporting groups
Overall Number of Baseline Participants 108 48 201 357
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 48 participants 201 participants 357 participants
<=18 years
108
 100.0%
48
 100.0%
201
 100.0%
357
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 48 participants 201 participants 357 participants
0.5  (1) 0.5  (1) 0.5  (1) 0.5  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 48 participants 201 participants 357 participants
Female
78
  72.2%
33
  68.8%
152
  75.6%
263
  73.7%
Male
30
  27.8%
15
  31.3%
49
  24.4%
94
  26.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 108 participants 48 participants 201 participants 357 participants
108 48 201 357
1.Primary Outcome
Title MRI/MRA of Head/Neck/Chest.
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Participants
Hide Arm/Group Description:
entire population count for MRI/A
Overall Number of Participants Analyzed 357
Measure Type: Number
Unit of Measure: participants
357
2.Primary Outcome
Title Clinical Diagnosis of PHACE Syndrome
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled in the large facial hemangioma arm (n= 108) were analyzed for this outcome measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
entire population count for MRI/A
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: Participants
33
3.Primary Outcome
Title Spinal Abnormalities
Hide Description The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled in the lumbrosacral hemangioma arm (n= 48) were analyzed for this outcome measure
Arm/Group Title All Participants
Hide Arm/Group Description:
entire population count for MRI/A
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Participants
21
4.Primary Outcome
Title Cerebrovascular and Structural Brain Abnormalities
Hide Description The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
entire population count for MRI/A
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Participants
31
5.Primary Outcome
Title Cardiac Abnormalities Detected Via Clinical Examination
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects diagnosed with clinically definite PHACE syndrome, enrolled in the large facial hemangioma arm (n= 33) were analyzed for this outcome measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
entire population count for MRI/A
Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: Participants
22
6.Primary Outcome
Title Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled in the hepatic hemangioma arm (n= 151) were analyzed for this outcome measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
entire population count for MRI/A
Overall Number of Participants Analyzed 151
Measure Type: Number
Unit of Measure: Participants
24
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Facial Hemangioma Lumbosacral Hemangioma Multiple Hemangiomas
Hide Arm/Group Description Patients with large facial hemangioma. Patients with lumbosacral hemangioma. Patients with multiple hemangiomas
All-Cause Mortality
Facial Hemangioma Lumbosacral Hemangioma Multiple Hemangiomas
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Facial Hemangioma Lumbosacral Hemangioma Multiple Hemangiomas
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/48 (0.00%)   0/201 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Facial Hemangioma Lumbosacral Hemangioma Multiple Hemangiomas
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/48 (0.00%)   0/201 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Beth Drolet
Organization: Medical College of Wisconsin
Phone: 414-266-1569
Responsible Party: Beth Drolet, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00394888     History of Changes
Other Study ID Numbers: High Risk Hemangioma
First Submitted: November 1, 2006
First Posted: November 2, 2006
Results First Submitted: May 4, 2011
Results First Posted: July 6, 2011
Last Update Posted: September 20, 2013