Optical Tomographic Imaging of Infantile Hemangiomas
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ClinicalTrials.gov Identifier: NCT01673971 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 28, 2012
Last Update Posted
: August 1, 2017
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Condition or disease |
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Infantile Hemangioma |
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.
Study Type : | Observational |
Actual Enrollment : | 15 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Official Title: | Optical Tomographic Imaging of Infantile Hemangiomas |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | January 1, 2018 |
Estimated Study Completion Date : | January 1, 2018 |

Group/Cohort |
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Natural History |
Treatment |
- Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin. [ Time Frame: Up to 2 years ]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.
- Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin. [ Time Frame: Up to 2 years ]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.
- Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points. [ Time Frame: Up to 2 years ]Measurements of absolute total hemoglobin concentration ([THb]) of the hemangioma are obtained at different time points and compared.
- Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points. [ Time Frame: Up to 2 years ]Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.

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Ages Eligible for Study: | up to 7 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673971
United States, New York | |
Columbia University Medical Center / Department of Dermatology | |
New York, New York, United States, 10032 |
Principal Investigator: | Maria Garzon, MD | Columbia University |
Responsible Party: | Maria Garzon, Professor of Clinical Dermatology and Clinical Pediatrics, Columbia University |
ClinicalTrials.gov Identifier: | NCT01673971 History of Changes |
Other Study ID Numbers: |
AAAJ1201 |
First Posted: | August 28, 2012 Key Record Dates |
Last Update Posted: | August 1, 2017 |
Last Verified: | July 2017 |
Keywords provided by Maria Garzon, Columbia University:
hemangioma |
Additional relevant MeSH terms:
Hemangioma Hemangioma, Capillary Port-Wine Stain Neoplasms, Vascular Tissue Neoplasms by Histologic Type |
Neoplasms Skin Abnormalities Congenital Abnormalities Skin Diseases |