Clinical Trials Directory

Trials / Completed

CompletedNCT01673971

Optical Tomographic Imaging of Infantile Hemangiomas

Status
Completed
Phase
Study type
Observational
Enrollment
15 (actual)
Sponsor
Columbia University · Academic / Other
Sex
All
Age
7 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Timeline

Start date
2012-05-01
Primary completion
2018-01-01
Completion
2018-01-01
First posted
2012-08-28
Last updated
2018-08-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01673971. Inclusion in this directory is not an endorsement.