Optical Tomographic Imaging of Infantile Hemangiomas
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Purpose
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.
| Condition |
|---|
|
Infantile Hemangioma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Optical Tomographic Imaging of Infantile Hemangiomas |
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2012 |
| Groups/Cohorts |
|---|
| Natural History |
| Treatment |
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.
Eligibility| Ages Eligible for Study: | up to 7 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Maria Garzon, MD | 212-305-5293 | mcg2@columbia.edu |
| Contact: Grace Ulerio | 212-305-6953 | gu2102@columbia.edu |
| United States, New York | |
| Columbia University Medical Center / Department of Dermatology | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Maria Garzon, MD 212-305-5293 mcg2@columbia.edu | |
| Contact: Grace Ulerio 212-305-6950 gu2102@columbia.edu | |
| Principal Investigator: Maria Garzon, MD | |
More Information
No publications provided
| Responsible Party: | Maria Garzon, Professor of Clinical Dermatology and Clinical Pediatrics, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01673971 History of Changes |
| Other Study ID Numbers: | AAAJ1201 |
| Study First Received: | August 24, 2012 |
| Last Updated: | August 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Columbia University:
|
hemangioma |
Additional relevant MeSH terms:
|
Hemangioma Hemangioma, Capillary Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013