Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 43 for:    Recruiting, Not yet recruiting, Available Studies | "Dwarfism"

Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03123003
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

Bone age assessment in children is based on the interpretation of hand x-ray scans according to Greulich and Pyle (GP) standard atlas and frequently used for evaluating growth and puberty in children and adolescents.

To address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, SonicBone was developed. SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves, propagating along a measured bone distance. The aim of the study is to evaluate an ultrasound based device, SonicBone, compared to the current method in children. The investigators will be compared the US assessment to available bone age X-ray that exists in the medical files of the patients. The investigators will not do bone age X-ray scans especially for the current study.


Condition or disease Intervention/treatment Phase
Short Stature Growth Disorders Device: SonicBone Ultrasound Device: Wrist X-ray Not Applicable

Detailed Description:

Bone age assessment in children is based on the interpretation of hand x-ray scans according to Greulich and Pyle standard atlas and frequently used for evaluating growth and puberty in children and adolescents.

To address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, SonicBone was developed. SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves, propagating along a measured bone distance. The aim of the study is to evaluate the ultrasound based device, SonicBone, and to compare it to the current method used in children.

The SonicBone device (Rishon Lezion, Israel) is a small (50cm X 25cm X 25cm), portable, bone sonometer, which measures two parameters:

  1. speed of propagation through bone (speed-of-sound, SOS, m/sec) of inaudible high frequency waves of a short ultrasound pulse; and
  2. attenuation (ATN; the decay rate) of the sound wave by the bone as a function of the distance it travels between a transmitter probe and a receiver probe15. The hand is measured by: 1- wrist (W), measuring SOS and ATN at the distal radius and ulna secondary ossification centers of the epiphyses; 2-metacarpals (MC), measuring SOS and ATN at the distal metacarpal epiphyses; and 3- phalange (P), measuring SOS and ATN along the bent proximal third phalanx shaft, growth plate and epiphysis. The average of those 3 readings is define as the child's bone age by SonicBone. All ultrasonic examinations will be conducted at the Pediatric Endocrinology Clinic, by a trained technician.

X-ray scans will be evaluated independently by a pediatric endocrinologist according to the GP atlas.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Arm Intervention/treatment
Experimental: SonicBone Ultrasound
Assessment of bone age by SonicBone Ultrasound will compared to wrist X-ray assessment
Device: SonicBone Ultrasound
Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.

Device: Wrist X-ray
Bone age assessment by Wrist X-ray




Primary Outcome Measures :
  1. bone age [ Time Frame: through study completion, an average of 1 year ]
    Bone age in years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   42 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 3.5-18 years old refered to the endocrine pediatric clinic due to short stature or other growth abnormalities

Exclusion Criteria:

  • Children with bone disease
  • Children who within the last year took medications which might change bone metabolism or mineralization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123003


Contacts
Layout table for location contacts
Contact: Alon Eliakim, Prof. 972-9-7471596 Eliakim.Alon@clalit.org.il
Contact: Dan Nemet, Prof. 972-9-7471596 Dan.Nemet@clalit.org.il

Locations
Layout table for location information
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Michal Pantanowitz, PhD    972-9-7471596    michalmirochnik@gmail.com   
Principal Investigator: Alon Eliakim, Prof.         
Sub-Investigator: Dan Nemet, Prof.         
Sub-Investigator: Michal Pantanowitz, PhD         
Sub-Investigator: Nitzan Dror, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Alon Eliakim, Prof. Meir Medical Center

Layout table for additonal information
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT03123003     History of Changes
Other Study ID Numbers: MeirMc0042-17CTIL
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meir Medical Center:
Bone age,
Height prediction
Growth

Additional relevant MeSH terms:
Layout table for MeSH terms
Dwarfism
Growth Disorders
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Pathologic Processes