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Clinical Deployment and Validation of Rho

Primary Purpose

Low Bone Density

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Opportunistic screening for low BMD
Sponsored by
16 Bit Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Low Bone Density focused on measuring osteoporosis, opportunistic, radiography, DXA

Eligibility Criteria

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

Inclusion Criteria:

  • age 50+ years
  • outpatient undergoing x-ray examinations of:
  • chest
  • thoracic spine
  • lumbar spine
  • pelvis
  • knee
  • hand/wrist

Exclusion Criteria:

  • age < 50 years
  • inpatient

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting
  • Holland Orthopaedic & Arthritic CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Opportunistic screening for low BMD

Arm Description

Outpatients aged over 50 years undergoing x-ray of the thoracic spine, lumbar spine, chest, pelvis, hand or knee will have their x-rays screened for low BMD by the software-as-a-medical device. If low BMD is identified by the software, a radiologist reviewing the x-ray may choose to incorporate this as an incidental finding in their report to the referring physician.

Outcomes

Primary Outcome Measures

Positive predictive value
To measure the positive screening rate for all patients screened by RhoTM and the positive predictive value (PPV) in those patients who screen positive by RhoTM and undergo follow-up DXA. PPV will be assessed for identification of low BMD (T-score <-1) and for identification of moderate/high fracture risk.

Secondary Outcome Measures

DXA conversion
To assess the DXA conversion rate defined as the proportion of patients who have a DXA within 6 months following a positively reported RhoTM screen. Scheduled DXA examinations may be used as a surrogate.

Full Information

First Posted
February 9, 2022
Last Updated
January 23, 2023
Sponsor
16 Bit Inc.
Collaborators
Amgen, Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05245851
Brief Title
Clinical Deployment and Validation of Rho
Official Title
Clinical Deployment and Validation of Rho - An Opportunistic Osteoporosis Screening Software-as-a-Medical Device
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
July 21, 2023 (Anticipated)
Study Completion Date
July 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
16 Bit Inc.
Collaborators
Amgen, Sunnybrook Health Sciences Centre

4. Oversight

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

5. Study Description

Brief Summary
Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed software, called RhoTM, that analyzes various x-rays, performed in patient age 50 and above for any clinical indication, to identify patients with low BMD. RhoTM is intended to function as a pre-screening device for low BMD. This study seeks to assess the clinical performance and impact of implementing RhoTM in real-world settings by analyzing its performance and impact on DXA referrals.
Detailed Description
Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed an opportunistic screening tool for low BMD, called RhoTM, that analyzes lumbar spine, thoracic spine, chest, pelvis, knee, and hand radiographs, performed in patient age 50 and above for any clinical indication to estimate lumbar and femoral neck BMD. The estimated BMD T-score is used to classify patients as having normal or low BMD. A finding of low BMD can be included in a radiologist's report, and is intended to support a discussion between healthcare provider and patient regarding the need for osteoporosis diagnosis by dual-energy x-ray absorptiometry (DXA). In this way, RhoTM is intended to function as an opportunistic pre-screening device for low BMD. This study seeks to assess the clinical performance and impact of implementing RhoTM in real-world settings by analyzing the diagnostic performance and impact on DXA referrals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Bone Density
Keywords
osteoporosis, opportunistic, radiography, DXA

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
16 Bit intends to study the impact of RhoTM by performing a prospective trial to assess its impact. A selected pilot site must have both x-ray and dual energy x-ray absorptiometry (DXA) imaging services, with the anticipation that DXA referrals will be made to the same imaging center which performed the x-ray which underwent RhoTM screening. The study population to assess the impact of RhoTM will consist of patients aged 50 and above who are opportunistically screened by RhoTM while undergoing an x-ray of the lumbar spine, thoracic spine, hand, knee, pelvis or chest.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opportunistic screening for low BMD
Arm Type
Experimental
Arm Description
Outpatients aged over 50 years undergoing x-ray of the thoracic spine, lumbar spine, chest, pelvis, hand or knee will have their x-rays screened for low BMD by the software-as-a-medical device. If low BMD is identified by the software, a radiologist reviewing the x-ray may choose to incorporate this as an incidental finding in their report to the referring physician.
Intervention Type
Device
Intervention Name(s)
Opportunistic screening for low BMD
Intervention Description
Software will analyze x-rays of the chest, thoracic spine, lumbar spine, pelvis, knee or hand/wrist acquired for any reason, and notify the radiologist at time of acquisition if low BMD is detected. The report to the radiologist includes the following statements: This x-ray was opportunistically analyzed by RhoTM, an investigational device under ITA [investigational testing authorization] from Health Canada, to screen for low bone mineral density (low BMD). This information should be used by a trained healthcare provider in conjunction with a patient's clinical fracture risk to determine if formal BMD screening with DXA is appropriate. The radiologist can choose to include this as an incidental finding in their report to the referring physician.
Primary Outcome Measure Information:
Title
Positive predictive value
Description
To measure the positive screening rate for all patients screened by RhoTM and the positive predictive value (PPV) in those patients who screen positive by RhoTM and undergo follow-up DXA. PPV will be assessed for identification of low BMD (T-score <-1) and for identification of moderate/high fracture risk.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
DXA conversion
Description
To assess the DXA conversion rate defined as the proportion of patients who have a DXA within 6 months following a positively reported RhoTM screen. Scheduled DXA examinations may be used as a surrogate.
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Radiologist adoption
Description
To assess radiologist adoption rate defined as the number of patients who are screened positive by RhoTM and for which the radiologist has included the findings of RhoTM in their report (i.e. a positively reported RhoTM screen) divided by the total number of positive RhoTM screens.
Time Frame
2 months
Title
Fracture risk assessment tool (FRAX) scores
Description
To compare the 10-year FRAX score as calculated using a DXA-derived T-score versus a Rho-derived T-score.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 50+ years outpatient undergoing x-ray examinations of: chest thoracic spine lumbar spine pelvis knee hand/wrist Exclusion Criteria: age < 50 years inpatient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regis Manorajah
Phone
416-480-6100
Ext
83787
Email
regis.manorajah@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasia Oikonomou, MD, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regis Menorajah
Email
regis.manorajah@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Anastasia Oikonomou, MD, PhD
Facility Name
Holland Orthopaedic & Arthritic Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regis Manorajah
Email
regis.manorajah@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Anastasia Oikonomou, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Deployment and Validation of Rho

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