Stereo Photogrammetry Imaging in Normal Volunteers and Patients With Head and Facial Malformations

Stereo Photogrammetry Soft Tissue in Normal Individuals and Patients With Craniofacial Dysmorphologies

This study will use stereo photogrammetry to: 1) characterize facial features of genetic and congenital malformations; 2) define facial features associated with normal growth and development; and 3) determine if stereo photogrammetry soft tissue imaging can be used to help diagnose head and facial malformations. These abnormalities currently are diagnosed using 2- or 3-dimensional skeletal images obtained with x-rays. Stereo photogrammetry uses a camera and computer to generate 3-dimensional images of the soft tissues of the face. Because the method does not use any radiation, images can be taken repeatedly to evaluate patients over a long term.

Using stereo photogrammetry, images of people who belong to a defined group, for example, 17-year-old Caucasian males, can be combined (or morphed) into one image, allowing measurement of the facial features of the group. Comparing the morphed images of a normal control group with those of people with specific genetic conditions may reveal distinctions that could be used in diagnosing conditions that are currently diagnosed using x-rays.

Healthy normal volunteers and patients with craniofacial dysmorphologies may be eligible for this study. Patients are recruited from current NIH studies of various genetic diseases. People who have previously had head and neck surgeries, including cosmetic surgery, may not participate.

Participants give a medical and dental history, including any orthodontic work or facial surgeries. They are then positioned in front of a photogrammetry camera, a headband is placed on their head, and their picture is taken. A coded patient number is entered into the computer, where the image is stored until further analysis. Most participants are evaluated one time, but some patients and control subjects may be asked to return yearly for repeat images.

Study Overview

Status

Completed

Detailed Description

In previous decades, analysis of craniofacial dysmorphologies have been conducted using two- or three-dimensional imaging of skeletal tissues acquired through radiography, with little analysis of soft tissue structures. The advantages of stereophotogrammetry surface scanning include easy image acquisition, the procedure is non-invasive, and images may be easily repeatedly taken for longitudinal evaluation of facial morphology. No radiation is used in acquiring these images.

The purposes of this study are to: 1) characterize the surface tissue facial features in different genetic diseases and syndromes; 2) define facial parameters of age-related growth and development; and 3) establish the use of stereophotogrammetry surface tissue imaging in aiding the diagnosis of genetic conditions and prediction of the clinic course of craniofacial dysmorphologies and associated genotypes.

Procedures will entail the acquisition of facial images from patients with known and suspected dysmorphologies as well as healthy controls. Facial parameters of various patient groups will be characterized in a standardized manner. In addition, composite (mean) images of patients with a particular diagnosis will be compared with controls using software algorithms. These facial parameters will be used to calculate the sensitivity and specificity of this technology to predict the genetic dysmorphology.

Study Type

Observational

Enrollment (Actual)

1813

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Minas Gerais, Brazil
        • Associacao dos Gemeos do Norte de Minas Gerais
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

    1. Male and female subjects of all ages and racial groups. The lower age limit will be determined by the ability to cooperate with imaging.
    2. Patient populations recruited from current NIH Intramural Studies with various defined genetic diseases such as Fanconi anemia.
    3. Controls recruited from the families of patients with genetic or congenital diseases, healthy volunteers participating in other NIH studies, or non-affected populations at collaborating institutions.

EXCLUSION CRITERIA:

  1. Patients or controls with a history of head and neck surgery to include cosmetic facial surgery.
  2. Patients unable to cooperate with imaging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 21, 2004

Study Completion

June 29, 2012

Study Registration Dates

First Submitted

December 31, 2004

First Submitted That Met QC Criteria

December 31, 2004

First Posted (ESTIMATE)

January 3, 2005

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

June 29, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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