Development of a Longitudinal Normative Dataset of Head Growth and Facial Development

Study ID
STU 112013-035

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Neil Stewart
214/456-5254
Neil.Stewart@UTSouthwestern.edu

Principal Investigator
Alex Kane, M.D.

Summary

under this proposal, we will develop an image repository of 3D stereophotogrammetric photographs taken annually from the time the child enters the school system to the time the child finishes schooling. This longitudinal 3D data of children's head growth and facial development will provide an unique dataset of normal growth that is not only of scientific importance in its own right but that also provides important control data against which to compare patients in both the clinical and research fields.

in order to identify participants and to collect these data, we have established a collaboration with a Dallas private school (Greenhill School, addison, TX) and will arrange to transport participants from their school to the analytical imaging and Modeling Center at Children's Medical Center, where the 3D images will be acquired. Greenhill School has in the region of 60 students per year in Kindergarten and 80 students per year in 1st Grade. We propose to recruit students from these two grades with an anticipated uptake of 50-100 participants. We also propose to extend our collaboration to other regional schools in future years to increase the number of students in this longitudinal dataset.

a reduced dataset of demographic information will be collected including name, gender, date of birth, height, weight, contact information and relevant medical history, if any. The investigators will obtain informed consent to include permission to acquire annual 3D stereophotogrammetry images until the participant leaves school, to archive these images to the repository, stored on a secured network, and to share these data for the purposes of teaching and research, which may include presentation at national or international meetings, and publication in scientific literature.

all the material on this repository is the property of its author or its institutions. Prior to accessing the repository data, researchers must provide verification of submission of a protocol and approval from the uT Southwestern iRB. iRB-approved Consent and HiPaa authorization will be required from all subjects or a Legally authorized Representative. uT Southwestern iRB approval must be current at all times to meet the aiM Lab requirements for accessing repository images. images may not be published without inclusion of this information in the iRB-approved Consent and HiPaa authorization and the permission of the Principal investigator.

Participants may be asked to remove makeup, accessories or clothing above the clavicles. a cap made of thin stocking-type material may be placed on the subjects head to cover the hair, as this may interfere with 3D stereophotogrammetry imaging. The expected duration of the subject's participation is less than 5 minutes, repeated annually.

Following acquisition, the images and associated demographic information will be stored on a secure network drive, indexed using a database administered through CMC. The aiM center has designated secure network storage, which will be used to archive the images. Hard copy data will be stored in locked files in the locked office of the aiM Lab. electronic data will be password-protected with access limited to members of the research team.

analysis of images for the purposes of research will require separate iRB approval and access to the shared network and data will only be granted to researchers upon written request after fulfilling all iRB and HiPPa requirements. image data may be analyzed with multiple quantitative mathematical morphometric techniques including, euclidean Distance Matrix analysis (eDMa), Principal Components analysis (PCa), and Fourier analysis, to cite a few example techniques. Data analysis will be performed using commercial software available at the aiM center. in addition, proprietary software algorithms (e.g. Matlab) may be developed. Reconstructed images and analyzed data will be stored on the secure network.

Participant Eligibility

Study subjects of all ages will include male and female healthy volunteers of all racial and ethnic origins. It is anticipated that participants will be children in the age range 5-18 years.