NCT03638674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 26, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

2.5 years

First QC Date

August 2, 2018

Last Update Submit

September 27, 2022

Conditions

Bone Fracture

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

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

    Day 0

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

    Day 0

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

    Day 0

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

    Day 0

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

    Day 0

  • +1 more secondary outcomes

Study Arms (4)

2nd lumbar spine acquisition in same position

ACTIVE COMPARATOR

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

Other: DXA + CT

2nd lumbar spine acquisition

ACTIVE COMPARATOR

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

Other: DXA + CT

2nd hip acquisition in same position

ACTIVE COMPARATOR

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

Other: DXA + CT

2nd hip acquisition

ACTIVE COMPARATOR

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

Other: DXA + CT

Interventions

DXA + CTOTHER

Two dual-energy X-ray scans + CT scan

2nd hip acquisition2nd hip acquisition in same position2nd lumbar spine acquisition2nd lumbar spine acquisition in same position

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details60 anatomical females and 60 anatomical males
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 20, 2018

Study Start

February 26, 2019

Primary Completion

August 20, 2021

Study Completion

December 1, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations

FR(1)