Optical Tomographic Imaging of Infantile Hemangiomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infantile Hemangioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Natural History

No interventions assigned to this group

Treatment

No interventions assigned to this group

Eligibility Criteria

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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.

* 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 of size \<2 cm in diameter
* Complicated IH requiring medical or surgical intervention
* IH located within 2 cm of the eye

* IH \<2 cm in size
* Complicated IH requiring surgical intervention
* IH located within 2 cm of the eye

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No