Overview

This trial is active, not recruiting.

Condition infantile hemangioma
Sponsor Columbia University
Start date May 2012
End date January 2016
Trial size 15 participants
Trial identifier NCT01673971, AAAJ1201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm

Primary Outcomes

Measure
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.
time frame: Up to 2 years
Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
time frame: Up to 2 years

Secondary Outcomes

Measure
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.
time frame: Up to 2 years
Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.
time frame: Up to 2 years

Eligibility Criteria

Male or female participants up to 7 years old.

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

Additional Information

Official title Optical Tomographic Imaging of Infantile Hemangiomas
Principal investigator Maria Garzon, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Columbia University.