Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury

Not Applicable

Terminated

• Conditions: Wrist Injury; Tibial Fracture; Hip Injury
• Interventions: Device: Standard X-Ray + CT; Device: Standard X-Ray + MRI; Device: TOMO

• Registration Number: NCT01927575
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief Summary

To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.

Detailed Description

Subjects presenting with a wrist injury, tibial fracture, or hip injury that require protocol defined standard imaging will have an X-Ray, CT Scan (or MRI per site preference) and TOMO completed. Images will be assessed to determine if TOMO is appropriate to supplement or replace the need for the other standard images.

Study Timeline

• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-22
• Study Start: 2013-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2016-09-09
• Results First Submitted QC: 2017-05-02
• Results First Posted: 2017-06-05
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Physician request to have diagnostic imaging for condition areas

Exclusion Criteria

• Under 18
• Pregnancy
• Insufficient Anatomical Coverage or Potential Image Problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tomo	Standard X-Ray + CT	Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Tomo	Standard X-Ray + MRI	Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Standard X-Ray + CT	TOMO	Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.
Standard X-Ray + MRI	Standard X-Ray + MRI	Standard X-Ray + MRI arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.
Standard X-Ray + MRI	TOMO	Standard X-Ray + MRI arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.
Tomo	TOMO	Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
Standard X-Ray + CT	Standard X-Ray + CT	Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.

Primary Outcome Measures

Name	Time	Method
Number of Participants for Whom Tibia Injury Was Detected	Baseline Imaging Collection	Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) \[or designee\] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.

Trial Locations

Locations (1)

Loyola University of Chicago; 🇺🇸 Maywood, Illinois, United States