Hemangioma Associated With High Rates of Morbidity (NCT00394888) | Clinical Trial Compass
CompletedNot Applicable
Hemangioma Associated With High Rates of Morbidity
United States433 participantsStarted 2005-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MRI/MRA of Head/Neck/Chest.
Timeframe: 2 years
2
Clinical Diagnosis of PHACE Syndrome
Timeframe: 2 years
3
Spinal Abnormalities
Timeframe: 2 years
4
Cerebrovascular and Structural Brain Abnormalities
Timeframe: 2 years
5
Cardiac Abnormalities Detected Via Clinical Examination
Timeframe: 2 years
6
Frequency of Hepatic Hemangiomas Detected Via Abdominal Ultrasound