Evaluation of Agreement Between CT Scan and 3D-DXA Measurements on the Lombar Spine

Bone Fracture Clinical Trial

— 3D DXA SPINE  

Official title:

Evaluation of Agreement Between CT Scan and 3D-DXA Measurements on the Lombar Spine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03638674
• Other study ID #: LOCAL/2016/VB-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dual-energy X-ray Absorptiometry is frequently used to measure bone mineral density. A new medical device, Box 3D DXA, creates a 3D image using a statistics reconstruction model developed on the femur. This new imaging technique does not require additional irradiation and ought to improve bone measures as well as incorporating densitometric parameters into the diagnosis. This study will test the reconstruction of the 3D image from lombar spine measurements and compare accuracy against measurements made using CT scan.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient is at least 18 years old
• The patient has been referred by a doctor for a PET/CT (Positron Emission Tomography-Computed Tomography) scan or a SPECT (Single Photon Emission Computed Tomography) scan in the Nuclear Medicine and Medical Biophysics Department of Nimes hospital or a bone scan including a SPECT/CT (single photon emission computed tomography coupled with a CT scan)

Exclusion Criteria:

• The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patients is under judicial protection or state guardianship
• The patient is pregnant or breast feeding
• The subject has a observably serious scoliosis
• Subject has previously had spinal or hip surgery
• Subject weighs more than 200kg and/or is more than 2 meters tall by 5+65cm wide and 70cm diameter
• Patient uses an insulin pump or wears an insulin or morphine tubing or any attenuating equipment affecting the hips or lumbar spine
• Subject has already had an X-ray exam using a contrast product such as barium in the 7 days preceding the visit
• Subject having undergone ? radiation exam in the 15 days preceding the visit

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone

Intervention

Other:
• DXA + CT
Two dual-energy X-ray scans + CT scan

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	DMS Apelem

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)	Lin's concordance coefficient	Day 0
Primary	Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)	Bland Altman plot	Day 0
Secondary	Reproducibility of the 3D-DXA Spine algorithm for lombar spine measurements	2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change	Day 0
Secondary	Robustness of 3D-DXA Spine measurement for lombar spine measurements	2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable	Day 0
Secondary	Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)	Lin's concordance coefficient	Day 0
Secondary	Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)	Bland Altman plot	Day 0
Secondary	Reproducibility of the 3D-DXA Femur algorithm for femur measurements	2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change	Day 0
Secondary	Robustness of 3D-DXA Femur measurement for femur measurements	2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable	Day 0