Optical Tomographic Imaging of Infantile Hemangiomas
N/A
7 Years
Both
Infantile Hemangioma
Trial Information
Optical Tomographic Imaging of Infantile 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.
Inclusion Criteria
For the 'Natural History' Cohort, the following inclusion and exclusion criteria apply:
INCLUSION CRITERIA:
- Infants with IH who present to our practices within the first 2 months of life.
- IH of size > 2 cm in diameter
- IH located on area of skin that is accessible to contact by 4x2cm probe. Examples
include the lateral face, forehead, scalp, trunk and areas of the extremities not
overlying joints.
Infants with IH that do not necessitate either medical or surgical intervention at time of
presentation.
EXCLUSION CRITERIA:
- IH of size <2 cm in diameter
- Complicated IH requiring medical or surgical intervention
- IH located within 2 cm of the eye
For the 'Treatment' Cohort, the following inclusion and exclusion criteria apply:
INCLUSION CRITERIA:
- Infants with IH who present to our practices within the first 2 months of life.
- IH of size >2 cm in diameter
- IH located on area of skin that is accessible to contact by 4x2cm probe. Examples
include the lateral face, forehead,scalp, trunk and areas of the extremities not
overlying joints.
- IH that necessitate medical intervention with either oral or topical betablockers.
EXCLUSION CRITERIA:
- IH <2 cm in size
- Complicated IH requiring surgical intervention
- IH located within 2 cm of the eye
Type of Study:
Observational
Study Design:
Observational Model: Cohort
Authority:
United States: Food and Drug Administration
Study ID:
AAAJ1201
NCT ID:
NCT01673971
Start Date:
May 2012
Completion Date:
Related Keywords:
- Infantile Hemangioma
- hemangioma
- Hemangioma
- Hemangioma, Capillary
Name | Location |
|---|---|
| Columbia University Medical Center / Department of Dermatology | New York, New York 10032 |
