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

Primary Purpose

Bone Fracture

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DXA + CT
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bone Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Nimes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

2nd lumbar spine acquisition in same position

2nd lumbar spine acquisition

2nd hip acquisition in same position

2nd hip acquisition

Arm Description

spine and hip STRATOS DR + 2nd lumbar spine acquisition in same position (with template)

spine and hip STRATOS DR + 2nd lumbar spine acquisition (no template)

spine and hip STRATOS DR + 2nd hip acquisition in same position (with template)

spine and hip STRATOS DR + 2nd hip acquisition (without template)

Outcomes

Primary Outcome Measures

Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Lin's concordance coefficient
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Bland Altman plot

Secondary Outcome Measures

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
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
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Lin's concordance coefficient
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Bland Altman plot
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
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

Full Information

First Posted
August 2, 2018
Last Updated
September 27, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
DMS Apelem
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1. Study Identification

Unique Protocol Identification Number
NCT03638674
Brief Title
Evaluation of Agreement Between CT Scan and 3D-DXA Measurements on the Lombar Spine
Acronym
3D DXA SPINE
Official Title
Evaluation of Agreement Between CT Scan and 3D-DXA Measurements on the Lombar Spine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
DMS Apelem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fracture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2nd lumbar spine acquisition in same position
Arm Type
Active Comparator
Arm Description
spine and hip STRATOS DR + 2nd lumbar spine acquisition in same position (with template)
Arm Title
2nd lumbar spine acquisition
Arm Type
Active Comparator
Arm Description
spine and hip STRATOS DR + 2nd lumbar spine acquisition (no template)
Arm Title
2nd hip acquisition in same position
Arm Type
Active Comparator
Arm Description
spine and hip STRATOS DR + 2nd hip acquisition in same position (with template)
Arm Title
2nd hip acquisition
Arm Type
Active Comparator
Arm Description
spine and hip STRATOS DR + 2nd hip acquisition (without template)
Intervention Type
Other
Intervention Name(s)
DXA + CT
Intervention Description
Two dual-energy X-ray scans + CT scan
Primary Outcome Measure Information:
Title
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Description
Lin's concordance coefficient
Time Frame
Day 0
Title
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Description
Bland Altman plot
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Reproducibility of the 3D-DXA Spine algorithm for lombar spine measurements
Description
2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change
Time Frame
Day 0
Title
Robustness of 3D-DXA Spine measurement for lombar spine measurements
Description
2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable
Time Frame
Day 0
Title
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Description
Lin's concordance coefficient
Time Frame
Day 0
Title
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Description
Bland Altman plot
Time Frame
Day 0
Title
Reproducibility of the 3D-DXA Femur algorithm for femur measurements
Description
2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change
Time Frame
Day 0
Title
Robustness of 3D-DXA Femur measurement for femur measurements
Description
2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable
Time Frame
Day 0

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
60 anatomical females and 60 anatomical males
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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