Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

Infantile Hemangiomas Clinical Trial

Official title:

Ontogeny and Quantitative Multimodal Skin Imaging of Infantile Hemangiomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061735
• Other study ID #: CHMC 2011-0443
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: May 5, 2015
• Start date: October 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

A combined set of quantitative skin imaging methods will quantitatively describe the natural ontogeny and the response to standard treatments over time in patients with infantile hemangiomas.

Description:

Infantile hemangiomas (IH) are relatively common benign vascular neoplasms, which appear shortly after birth and grow rapidly in the following weeks and months. The proliferative phase involves a rapidly dividing endothelial cell proliferation. The tumors generally stabilize and then involute over time. They are usually clinically insignificant; however, a small percentage of them can be life threatening secondary to location, associated syndrome, and physical findings such as ulceration. Treatment options have included steroids, interferon, vincristine and more recently propranolol. There are few published prospective research studies on the effectiveness of these treatment options. Because of several factors, it has been difficult to objectively measure response of these lesions. The purpose is to determine (1) whether multiple quantitative skin imaging modalities can quantitatively describe the clinically relevant features of infantile hemangiomas, including color (red, blue), lightness, size (height, volume), biomechanical properties, temperature and perfusion and (2) the natural ontogeny and response to treatment over time. The treatments are oral propranolol, topical timolol and untreated (observation).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

• Age = 5 years of age

• Diagnosis of a cutaneous infantile hemangioma

• Diagnosis of hemangioma requiring treatment (treatment includes: propranolol or topical timolol) or diagnosis of an infantile hemangioma that will not be treated at the time of enrollment

• Able to tolerate imaging procedures

Exclusion Criteria:

• Age > 5 years

• Non cutaneous infantile hemangioma

• Hemangioma on the lip

• Hemangioma on the eyelid

• Hemangioma located in areas whereby measurements cannot be made due to equipment limitations

• Deep hemangioma with no visible skin surface component

• Congenital hemangioma

• No available normal site for study control

• Other vascular anomaly

• Not able to tolerate imaging procedures

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma, Capillary
• Infantile Hemangiomas
• Port-Wine Stain

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Society for Pediatric Dermatology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemangioma height	IH height and volume will be obtained from surface scans with the Artec scanner with a 0.5 mm resolution, 0.1 mm accuracy, at 60 cm. Three dimensional scans will be created with the Artec Studio software and features quantified with the three dimensional software. Soft tissue landmarks will create the region of interest for all evaluations. Height and volume will be calculated for the infantile hemangioma versus the control.	up to 5 years	No
Primary	Static and Dynamic Temperature	Temperature information will be acquired with a thermal imaging camera with analysis software. The thermal features of the surrounding uninvolved control skin are removed by applying thresholds. Static infrared thermography captures the steady-state condition and spatial distribution. Dynamic infrared thermography applies a stress (cooling) to stimulate the thermal response within the tissue.	up to 5 years	No
Primary	Skin color and lightness	High resolution color Images will be taken taken with a digital camera, Micro 60 mm lens with a wireless close up flash system at 30cm and perpendicular to the site. The images are color corrected and processed into three distinct images : red color, blue-yellow color, and lightness (white - back).; Color and thermal images are co-registered and analyzed with customized software. The system creates quantitative outputs and maps for visualization of IH regions of thermal and color activity. Threshold values for the lightness, red color, blue color and thermal images are selected based upon histogram distributions of the uninvolved skin as the values above the mean and multiple standard deviations The pixels beyond the thresholds are used to quantify and map the features due to the hemangioma itself.	up to 5 years	No
Secondary	Biomechanical properties	Tissue mechanical properties (i.e., elasticity, elastic deformation, laxity, stiffness, etc.) will be measured to assess tissue deformability. The instrument measures biomechanical properties of the skin by applying a negative pressure, in the range between 20 and 500 mbar. These properies are compared to an uninvolved contralateral control site.	up to 5 years	No