Optical Tomographic Imaging of Infantile Hemangiomas

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Maria Garzon, Columbia University
ClinicalTrials.gov Identifier:
NCT01673971
First received: August 24, 2012
Last updated: February 26, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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.

  • Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Measurements of absolute total hemoglobin concentration ([THb]) of the hemangioma are obtained at different time points and compared.

  • Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Measurements of tissue oxygen saturation (StO2) of the hemangioma are obtained at different time points and compared.


Estimated Enrollment: 15
Study Start Date: May 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673971

Locations
United States, New York
Columbia University Medical Center / Department of Dermatology
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
  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: February 26, 2014
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 August 01, 2014