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

NCT ID: NCT03638674

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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2nd lumbar spine acquisition in same position

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

Group Type ACTIVE_COMPARATOR

DXA + CT

Intervention Type OTHER

Two dual-energy X-ray scans + CT scan

2nd lumbar spine acquisition

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

Group Type ACTIVE_COMPARATOR

DXA + CT

Intervention Type OTHER

Two dual-energy X-ray scans + CT scan

2nd hip acquisition in same position

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

Group Type ACTIVE_COMPARATOR

DXA + CT

Intervention Type OTHER

Two dual-energy X-ray scans + CT scan

2nd hip acquisition

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

Group Type ACTIVE_COMPARATOR

DXA + CT

Intervention Type OTHER

Two dual-energy X-ray scans + CT scan

Interventions

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DXA + CT

Two dual-energy X-ray scans + CT scan

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DMS Apelem

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2016/VB-01

Identifier Type: -

Identifier Source: org_study_id

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