Optical Tomographic Imaging of Infantile Hemangiomas

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.

Study Overview

• Status: Completed
• Conditions: Infantile Hemangioma

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center / Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All subjects will be recruited verbally from the pediatric dermatology faculty practices, clinics and inpatient services at CUMC/NYP (MSCHONY). In accordance with CUMC policy, researchers will not approach a patient for recruitment until that patient has been informed of the study by their treating physician who has ascertained the patient's willingness to discuss the study with the investigators.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Natural History
Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Maria Garzon, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: August 24, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: hemangioma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Congenital Abnormalities; Skin Abnormalities; Neoplasms, Vascular Tissue; Hemangioma, Capillary; Port-Wine Stain; Hemangioma
• Other Study ID Numbers: AAAJ1201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No