Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Primary Purpose
Short Stature, Growth Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SonicBone Ultrasound
Wrist X-ray
Sponsored by
About this trial
This is an interventional diagnostic trial for Short Stature focused on measuring Bone age,, Height prediction, Growth
Eligibility 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
Sites / Locations
- Meir Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SonicBone Ultrasound
Arm Description
Assessment of bone age by SonicBone Ultrasound will compared to wrist X-ray assessment
Outcomes
Primary Outcome Measures
bone age
Bone age in years
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03123003
Brief Title
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Official Title
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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:
speed of propagation through bone (speed-of-sound, SOS, m/sec) of inaudible high frequency waves of a short ultrasound pulse; and
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature, Growth Disorders
Keywords
Bone age,, Height prediction, Growth
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SonicBone Ultrasound
Arm Type
Experimental
Arm Description
Assessment of bone age by SonicBone Ultrasound will compared to wrist X-ray assessment
Intervention Type
Device
Intervention Name(s)
SonicBone Ultrasound
Intervention Description
Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.
Intervention Type
Device
Intervention Name(s)
Wrist X-ray
Intervention Description
Bone age assessment by Wrist X-ray
Primary Outcome Measure Information:
Title
bone age
Description
Bone age in years
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Eliakim, Prof.
Phone
972-9-7471596
Email
Eliakim.Alon@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Nemet, Prof.
Phone
972-9-7471596
Email
Dan.Nemet@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alon Eliakim, Prof.
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Pantanowitz, PhD
Phone
972-9-7471596
Email
michalmirochnik@gmail.com
First Name & Middle Initial & Last Name & Degree
Alon Eliakim, Prof.
First Name & Middle Initial & Last Name & Degree
Dan Nemet, Prof.
First Name & Middle Initial & Last Name & Degree
Michal Pantanowitz, PhD
First Name & Middle Initial & Last Name & Degree
Nitzan Dror, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray
We'll reach out to this number within 24 hrs