Optical Tomographic Imaging of Infantile Hemangiomas

Columbia University

Status: Completed

Conditions: Infantile Hemangioma

Study type: Observational

Funder types: Other

Identifiers

NCT01673971

AAAJ1201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: Under 7 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

15 participants in 2 patient groups

Natural History

Treatment