search
Back to results

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

Primary Purpose

Craniofacial Abnormalities

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Dental and Craniofacial Research (NIDCR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Craniofacial Abnormalities focused on measuring Facial Imaging, Genetics, Growth, Development, Diagnostics, Craniofacial Dysmorphologies, Facial Features

Eligibility Criteria

1 Year - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: Male and female subjects of all ages and racial groups. The lower age limit will be determined by the ability to cooperate with imaging. Patient populations recruited from current NIH Intramural Studies with various defined genetic diseases such as Fanconi anemia. 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: Patients or controls with a history of head and neck surgery to include cosmetic facial surgery. Patients unable to cooperate with imaging.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike
  • Associacao dos Gemeos do Norte de Minas Gerais
  • Universidad Peruana Cayetano Heredia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 31, 2004
Last Updated
December 3, 2019
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
search

1. Study Identification

Unique Protocol Identification Number
NCT00100529
Brief Title
Stereo Photogrammetry Imaging in Normal Volunteers and Patients With Head and Facial Malformations
Official Title
Stereo Photogrammetry Soft Tissue in Normal Individuals and Patients With Craniofacial Dysmorphologies
Study Type
Observational

2. Study Status

Record Verification Date
June 29, 2012
Overall Recruitment Status
Completed
Study Start Date
December 21, 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 29, 2012 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Abnormalities
Keywords
Facial Imaging, Genetics, Growth, Development, Diagnostics, Craniofacial Dysmorphologies, Facial Features

7. Study Design

Enrollment
1813 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Male and female subjects of all ages and racial groups. The lower age limit will be determined by the ability to cooperate with imaging. Patient populations recruited from current NIH Intramural Studies with various defined genetic diseases such as Fanconi anemia. 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: Patients or controls with a history of head and neck surgery to include cosmetic facial surgery. Patients unable to cooperate with imaging.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol W Bassim, D.M.D.
Organizational Affiliation
National Institute of Dental and Craniofacial Research (NIDCR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Associacao dos Gemeos do Norte de Minas Gerais
City
Minas Gerais
Country
Brazil
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
15382685
Citation
Li Y, Shum HY, Tang CK, Szeliski R. Stereo reconstruction from multiperspective panoramas. IEEE Trans Pattern Anal Mach Intell. 2004 Jan;26(1):45-62. doi: 10.1109/tpami.2004.1261078.
Results Reference
background
PubMed Identifier
10682900
Citation
Hart TC, Marazita ML, Wright JT. The impact of molecular genetics on oral health paradigms. Crit Rev Oral Biol Med. 2000;11(1):26-56. doi: 10.1177/10454411000110010201.
Results Reference
background
PubMed Identifier
15376889
Citation
Szeliski R, Scharstein D. Sampling the disparity space image. IEEE Trans Pattern Anal Mach Intell. 2004 Mar;26(3):419-25. doi: 10.1109/TPAMI.2004.1262341.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs