An observational study in Infantile Hemangioma, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2018-08-06.
Sponsored by Columbia University · Observational
The investigators hypothesize that there are differences between infantile hemangiomas (IH) during the proliferating and involuting phases and in response to medical treatment that can be detected by optical tomography of these hemangiomas.
Infantile hemangiomas (IH) are common vascular growths that frequently arise in infants. The clinical presentation is variable, and some hemangiomas have the potential to cause disfiguring and even lifethreatening complications. While there is no FDA approved treatment for IH, certain medications have been shown to be effective in shrinking the growths. Unfortunately, there is no objective tool to monitor IH or to guide treatment. Such a tool would improve the management of these patients. A new handheld wireless device uses diffuse optical imaging (DOI) technology to measure blood flow characteristics.
The device has been used in studies to assess patients with breast cancer. Optical tomography has also been increasingly used to assess neurological function and pathology in newborn infants.
The goal of the investigators' study is to assess the utility of DOI for characterizing and monitoring IH. Fifteen IH will be assessed at three points in time as part of this study, comprising two groups: 'Natural History' and 'Treatment'. DOI measurements will be correlated with clinical findings and existing ultrasound measurements of the IH.
141 studies on the registry are indexed under Hemangioma; 16 are open to participants now.
This study's enrollment of 15 is below the median of 79 across 56 observational studies indexed under Hemangioma.
Browse Hemangioma studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
All subjects will be recruited verbally from the pediatric dermatology faculty practices, clinics and inpatient services at CUMC/NYP (MSCHONY). In accordance with CUMC policy, researchers will not approach a patient for recruitment until that patient has been informed of the study by their treating physician who has ascertained the patient's willingness to discuss the study with the investigators.
For the 'Natural History' Cohort, the following inclusion and exclusion criteria apply:
INCLUSION CRITERIA:
Infants with IH that do not necessitate either medical or surgical intervention at time of presentation.
EXCLUSION CRITERIA:
For the 'Treatment' Cohort, the following inclusion and exclusion criteria apply:
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.
Measurements of absolute total hemoglobin concentration (\[THb\]) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
Time frame: Up to 2 years
Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
Measurements of tissue oxygen saturation (StO2) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
Time frame: Up to 2 years
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.
Measurements of absolute total hemoglobin concentration (\[THb\]) of the hemangioma are obtained at different time points and compared.
Time frame: Up to 2 years
Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.
Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.
Time frame: Up to 2 years
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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