Optical Tomographic Imaging of Infantile Hemangiomas

Completed

• Conditions: Infantile Hemangioma

• Registration Number: NCT01673971
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-28
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.	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 and normal skin.	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.

Secondary Outcome Measures

Name	Time	Method
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.	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.	Up to 2 years	Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.

Trial Locations

Locations (1)

Columbia University Medical Center / Department of Dermatology; 🇺🇸 New York, New York, United States