HemangiomaNCT00394888
Hemangioma Associated With High Rates of Morbidity
A study testing MRI, MRI of head and neck and Dermatological Examination in people with Hemangioma, run by Medical College of Wisconsin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hemangioma
- What is being tested?
- MRI, MRI of head and neck and Dermatological Examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemangioma Associated With High Rates of Morbidity:A Prospective Study
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.
Read the detailed 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.
- Conditions
- Hemangioma
- Being tested
- MRI, MRI of head and neck, Dermatological Examination, Cardiac examination, Abdominal ultrasound
- Keywords
- Hemangioma, PHACE, Lumbosacral hemangioma, Occult Spinal Dysraphism
- Medical subject headings
- Hemangioma, Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI of the spine.
MRI of head and neckDevice
MRI of head and C-spine
Dermatological ExaminationOther
Also called Clinical dermatological examination
Complete dermatological examination to identify and characterize nature of dermatological anomalies
Cardiac examinationOther
Also called Cardiovascular examination
Complete cardiac examination
Abdominal ultrasoundDevice
Abdominal ultrasound to detect hepatic hemangiomas
| Study group | Role | What they receive |
|---|---|---|
| Facial Hemangioma | Other | Patients with large facial hemangioma. Receives: Device: MRI of head and neck; Other: Dermatological Examination; Other: Cardiac examination |
| Lumbosacral Hemangioma | Other | Patients with lumbosacral hemangioma. Receives: Device: MRI; Other: Dermatological Examination |
| Multiple Hemangiomas | Other | patients with multiple hemangiomas (>5) Receives: Device: MRI; Other: Dermatological Examination; Device: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI/MRA of Head/Neck/Chest.
Measured: 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.
Measured: 2 years
Spinal Abnormalities
The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.
Measured: 2 years
Cerebrovascular and Structural Brain Abnormalities
The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startNov 2005
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Beth Drolet, Medical College of Wisconsin
- Investigators
- Beth Drolet, MD, Principal investigator, Medical College of WisconsinMaria Garzon, MD, Principal investigator, Columbia UniversityDenise Metry, MD, Principal investigator, Baylor College of MedicineIlona Frieden, MD, Principal investigator, University of California, San FranciscoJulie Powell, MD, Principal investigator, Hopital Sainte-JustineAnne Lucky, MD, Principal investigator, Children's Hospital of CincinnatiSharon Glick, MD, Principal investigator, State University of New York - Downstate Medical CenterEulalia Baselga, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394888
- Sponsor's protocol ID
- High Risk Hemangioma
- Status last verified
- Sep 2013
- First submitted
- 1 Nov 2006
- Last updated
- 20 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemangioma Associated With High Rates of Morbidity:A Prospective Study
- ClinicalTrials.gov ID
- NCT00394888
- Acronym / sponsor ID
- High Risk Hemangioma
- Conditions
- Hemangioma
- Keywords
- Hemangioma, PHACE, Lumbosacral hemangioma, Occult Spinal Dysraphism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- 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
- Study start
- Nov 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Posted 6 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facial Hemangioma | Other | Device: MRI of head and neck, Other: Dermatological Examination, Other: Cardiac examinationPatients with large facial hemangioma. |
| Lumbosacral Hemangioma | Other | Device: MRI, Other: Dermatological ExaminationPatients with lumbosacral hemangioma. |
| Multiple Hemangiomas | Other | Device: MRI, Other: Dermatological Examination, Device: Abdominal ultrasoundpatients with multiple hemangiomas (>5) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI of the spine. | Device | Lumbosacral Hemangioma, Multiple Hemangiomas |
| MRI of head and neckMRI of head and C-spine | Device | Facial Hemangioma |
| Dermatological ExaminationAlso: Clinical dermatological examinationComplete dermatological examination to identify and characterize nature of dermatological anomalies | Other | Facial Hemangioma, Lumbosacral Hemangioma, Multiple Hemangiomas |
| Cardiac examinationAlso: Cardiovascular examinationComplete cardiac examination | Other | Facial Hemangioma |
| Abdominal ultrasoundAbdominal ultrasound to detect hepatic hemangiomas | Device | Multiple Hemangiomas |
Primary outcome
MRI/MRA of Head/Neck/Chest.
Time frame: 2 years
Clinical Diagnosis of PHACE Syndrome
Time frame: 2 years
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.
Spinal Abnormalities
Time frame: 2 years
The number of lumbrosacral hemangioma subjects with confirmed spinal abnormalities detected via lumbrosacral MRI.
Cerebrovascular and Structural Brain Abnormalities
Time frame: 2 years
The number of PHACE subjects identified with cerebrovascular and/or structural brain abnormalities detected using MRI.
Cardiac Abnormalities Detected Via Clinical Examination
Time frame: 2 years
The number of subjects with clinically definite PHACE syndrome who were identified as having cardiac abnormalities following clinical examination.
Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound
Time frame: 2 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Drolet, MD principal investigator
Medical College of Wisconsin
Maria Garzon, MD principal investigator
Columbia University
Denise Metry, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, MRI of head and neck and Dermatological Examination in people with Hemangioma, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI/MRA of Head/Neck/Chest. (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.