Ontogeny of Infantile Hemangiomas With Skin Imaging Modalities

NCT02061735 | Completed

• 1 other identifier: CHMC 2011-0443
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infantile Hemangiomas

Keywords

skin imaging; image analysis; infrared thermography; infantile hemangioma; three dimensional imaging; color imaging and analysis; propranolol; timolol; ontogeny

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (1)

• Biomechanical properties

  up to 5 years

Study Arms (3)

oral propranolol

Dosage of 1 mg/kg per day divided 2 times daily. Blood pressure, heart rate and oxygen saturation are monitored after propranolol initiation. Treatment is continued with a gradual increase to 2 mg/kg per day divided 2 times daily. Treatment is continued until the hemangioma no longer changes in the characteristics judged by the physicians, including, color, size, temperature and deformability.

timolol maleate 0.5% gel

One drop of of timolol maleate 0.5% gel is topically applied and massaged into the hemangioma twice per day . This dosage provides an estimated 0.5 mg of timolol per day. The treatment is continued until it is considered to be no longer effective as judged by the physicians.

No treatment, observation only

No oral or topical treatment will be given as recommended by the treating physicians and elected by the parents. Patients will be evaluated periodically to determine what changes in treatment are warranted. If this occurs, the patients will be included in the appropriate study group.

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients being seen at the the Hemangioma and Vascular Malformation Center of Cincinnati Children's Hospital Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Society for Pediatric Dermatology: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Burkes SA, Patel M, Adams DM, Hammill AM, Eaton KP, Randall Wickett R, Visscher MO. Infantile hemangioma status by dynamic infrared thermography: A preliminary study. Int J Dermatol. 2016 Oct;55(10):e522-32. doi: 10.1111/ijd.13298. Epub 2016 Apr 8.

  PMID: 27062495 DERIVED

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Marty O Visscher, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Denise Adams, MD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

• Adrienne Hammill, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: October 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

US (1)