Optical Tomographic Imaging of Infantile Hemangiomas

Infantile Hemangioma Clinical Trial

Official title:

Optical Tomographic Imaging of Infantile Hemangiomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673971
• Other study ID #: AAAJ1201
• Status: Completed
• Start date: May 2012
• Est. completion date: January 1, 2018

Study information

• Verified date: August 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Infantile Hemangioma
• Port-Wine Stain

Locations

Country	Name	City	State
United States	Columbia University Medical Center / Department of Dermatology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.	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.	Up to 2 years
Primary	Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.	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.	Up to 2 years
Secondary	Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.	Measurements of absolute total hemoglobin concentration ([THb]) of the hemangioma are obtained at different time points and compared.	Up to 2 years
Secondary	Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.	Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.	Up to 2 years