Optical Tomographic Imaging of Infantile Hemangiomas

NCT01673971 | Completed DMC

• 1 other identifier: AAAJ1201
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infantile Hemangioma

Keywords

hemangioma

Outcome Measures

Primary Outcomes (2)

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

  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.

  Up to 2 years

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

  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.

  Up to 2 years

Secondary Outcomes (2)

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

  Up to 2 years

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

  Up to 2 years

Study Arms (2)

Natural History

Treatment

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• 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.
• IH of size \<2 cm in diameter
• Complicated IH requiring medical or surgical intervention
• IH located within 2 cm of the eye
• 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.
• IH \<2 cm in size
• Complicated IH requiring surgical intervention
• IH located within 2 cm of the eye

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center / Department of Dermatology

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Hemangioma, Capillary; Hemangioma

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Maria Garzon, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Dermatology and Clinical Pediatrics

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 28, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-08

Locations

US (1)