Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03951220 · OUTCOME

Primary Outcome 1+2: Quantifying Tumour Burden [Osteotronix Fine Structural Analysis (FSA), Trabecular Wall Thickness]

The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss · Source last updated 2025-08-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
At baseline

What was measured

* Osteotronix' fineSA® (Fine Structural Analysis, FSA) technology extracts microstructural information from Magnetic Resonance Imaging (MRI) data sets, as a correlate of trabecular wall thickness, to indicate bone remodelling. The FSA metric has been shown to correlate tightly with gold standard bone density measurements in rats \[Evans et al, 2014\] and human cadaveric spine specimens \[Rafferty et al, 2016\]. * In this study, we had collected data during the novel MR protocol at both baseline and follow-up time points. However, we were unable to complete analysis of the FSA metrics, because of disruptions due to COVID-19, therefore the results have not been possible to report.

Analysis population: \- In this study, we had collected data during the novel MR protocol at both baseline and follow-up time points. However, we were unable to complete analysis of the FSA metrics as the company we contracted to undertake this was dissolved, an alternative is not available and there is no remaining budget. Therefore the results will never be possible to report.

Groups in this outcome

Group 1- Myeloma

Group 1a: New Myeloma; Group 1b: Relapsed Myeloma Group;1c: Smouldering Myeloma Baseline AND Follow-Up Assessment: Novel MR Whole body DXA scan Blood and urine samples QOL \& scan experience questionnaires

Group 2- MGUS

Baseline AND Follow-Up Assessment: Novel MR Whole body DXA scan Blood and urine samples QOL \& scan experience questionnaires

Group 3- Healthy Volunteers

Baseline Assessment ONLY: * Novel MR * QOL \& scan experience questionnaires

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma0
Group 2- MGUS0
Group 3- Healthy Volunteers0

Reported measurements

Fine Structural Analysis Trabecular Wall Thickness
Fine Structural Analysis Trabecular Wall Separation
Complete source fields
classes
  1. title
    Fine Structural Analysis Trabecular Wall Thickness
  2. title
    Fine Structural Analysis Trabecular Wall Separation
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
* Osteotronix' fineSA® (Fine Structural Analysis, FSA) technology extracts microstructural information from Magnetic Resonance Imaging (MRI) data sets, as a correlate of trabecular wall thickness, to indicate bone remodelling. The FSA metric has been shown to correlate tightly with gold standard bone density measurements in rats \[Evans et al, 2014\] and human cadaveric spine specimens \[Rafferty et al, 2016\]. * In this study, we had collected data during the novel MR protocol at both baseline and follow-up time points. However, we were unable to complete analysis of the FSA metrics, because of disruptions due to COVID-19, therefore the results have not been possible to report.
groups
  1. description
    Group 1a: New Myeloma; Group 1b: Relapsed Myeloma Group;1c: Smouldering Myeloma Baseline AND Follow-Up Assessment: Novel MR Whole body DXA scan Blood and urine samples QOL \& scan experience questionnaires
    id
    OG000
    title
    Group 1- Myeloma
  2. description
    Baseline AND Follow-Up Assessment: Novel MR Whole body DXA scan Blood and urine samples QOL \& scan experience questionnaires
    id
    OG001
    title
    Group 2- MGUS
  3. description
    Baseline Assessment ONLY: * Novel MR * QOL \& scan experience questionnaires
    id
    OG002
    title
    Group 3- Healthy Volunteers
population Description
\- In this study, we had collected data during the novel MR protocol at both baseline and follow-up time points. However, we were unable to complete analysis of the FSA metrics as the company we contracted to undertake this was dissolved, an alternative is not available and there is no remaining budget. Therefore the results will never be possible to report.
reporting Status
POSTED
time Frame
At baseline
title
Primary Outcome 1+2: Quantifying Tumour Burden [Osteotronix Fine Structural Analysis (FSA), Trabecular Wall Thickness]
type
PRIMARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice