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Completed

NCT Number: NCT01673971

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.

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Key information

Conditions

Infantile Hemangioma Hemangioma Hemangioma, Capillary Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center / Department of Dermatology

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.

    Time frame: 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.

  2. Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.

    Time frame: 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.

Secondary outcomes

  1. Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.

    Time frame: Up to 2 years

    Measurements of absolute total hemoglobin concentration ([THb]) of the hemangioma are obtained at different time points and compared.

  2. Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.

    Time frame: Up to 2 years

    Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2012
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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