NCT00100529

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,813

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2004

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2005

Completed
7.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2012

Completed
Last Updated

December 4, 2019

Status Verified

June 29, 2012

First QC Date

December 31, 2004

Last Update Submit

December 3, 2019

Conditions

Keywords

Facial ImagingGeneticsGrowthDevelopmentDiagnosticsCraniofacial DysmorphologiesFacial Features

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Associacao dos Gemeos do Norte de Minas Gerais

Minas Gerais, Brazil

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Related Publications (3)

  • 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.

    PMID: 15382685BACKGROUND
  • 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.

    PMID: 10682900BACKGROUND
  • 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.

    PMID: 15376889BACKGROUND

MeSH Terms

Conditions

Craniofacial Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Carol W Bassim, D.M.D.

    National Institute of Dental and Craniofacial Research (NIDCR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 31, 2004

First Posted

January 3, 2005

Study Start

December 21, 2004

Study Completion

June 29, 2012

Last Updated

December 4, 2019

Record last verified: 2012-06-29

Locations