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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Fracture
• Intervention / Treatment: Other: DXA + CT

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 γ radiation exam in the 15 days preceding the visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2nd lumbar spine acquisition in same position; spine and hip STRATOS DR + 2nd lumbar spine acquisition in same position (with template)	Other: DXA + CT; Two dual-energy X-ray scans + CT scan
Active Comparator: 2nd lumbar spine acquisition; spine and hip STRATOS DR + 2nd lumbar spine acquisition (no template)	Other: DXA + CT; Two dual-energy X-ray scans + CT scan
Active Comparator: 2nd hip acquisition in same position; spine and hip STRATOS DR + 2nd hip acquisition in same position (with template)	Other: DXA + CT; Two dual-energy X-ray scans + CT scan
Active Comparator: 2nd hip acquisition; spine and hip STRATOS DR + 2nd hip acquisition (without template)	Other: DXA + CT; Two dual-energy X-ray scans + CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)	Lin's concordance coefficient	Day 0
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)	Bland Altman plot	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)	Lin's concordance coefficient	Day 0
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)	Bland Altman plot	Day 0
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: DMS Apelem

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Actual): August 20, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: LOCAL/2016/VB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No