Skip to main content
OpenTrials
Completed

NCT Number: NCT03638674

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Fracture Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DXA + CT

Other

Two dual-energy X-ray scans + CT scan

Primary outcomes

  1. Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)

    Time frame: Day 0

    Lin's concordance coefficient

  2. Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)

    Time frame: Day 0

    Bland Altman plot

Secondary outcomes

  1. Reproducibility of the 3D-DXA Spine algorithm for lombar spine measurements

    Time frame: Day 0

    2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change

  2. Robustness of 3D-DXA Spine measurement for lombar spine measurements

    Time frame: Day 0

    2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable

  3. Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)

    Time frame: Day 0

    Lin's concordance coefficient

  4. Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)

    Time frame: Day 0

    Bland Altman plot

  5. Reproducibility of the 3D-DXA Femur algorithm for femur measurements

    Time frame: Day 0

    2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change

  6. Robustness of 3D-DXA Femur measurement for femur measurements

    Time frame: Day 0

    2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • DMS Apelem

Registry information

Acronym: 3D DXA SPINE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2018
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.