Diagnostic Imaging of Myeloma Bone Lesions (RAMP)

May 8, 2017 updated by: Eva Dyrberg Mortensen, Herlev Hospital

The Diagnostic Value of FDG-PET-CT, NaF-PET-CT and Whole-body MRI Compared to Whole-body Xray in the Detection of Bone Lesions in Multiple Myeloma Patients

The purpose of this study is to compare the current standard whole-body x-ray with the advanced imaging techniques FDG-PET-CT, NaF-PET-CT and whole-body MRI in the detection of myeloma bone lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Accurate detection of bone lesions in myeloma patients is essential for treatment planning and patient survival.

Newly diagnosed multiple myeloma patients can be enrolled in this study. All participants will at time of diagnosis undergo three project scans (FDG-PET-CT, NaF-PET-CT, whole-body MRI) as well as whole-body x-ray as part of clinical routine practice.

Experienced specialists in the field of radiology and nuclear medicine interpret the images. Each reader performs the evaluations blinded to other imaging results as well as to the patient's clinical information. The reader assesses whether myeloma indicative bone lesions are present in eight predefined skeletal body regions.

Endpoint is purely diagnostic.

Statistics:

Cochran's Q-test: to compare the proportion of patients with bone disease detected by the four scanning methods.

Two-sided ANOVA: to compare the average number of regions detected with bone disease by the four scanning methods.

Tukey's comparison test: to compare the difference between each pair of means.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Department of Radiology/Department of Nuclear Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed multiple myeloma (biopsy proven)

Exclusion Criteria:

  • Prior malignancy
  • Are not able to undergo a MRI scan due to MRI contraindications (e.g. pacemaker)
  • Has any condition that places the subject at an unacceptable risk if he/she undergoes a diagnostic CT scan with iv. contrast (e.g. history of severe allergic reaction to the contrast agent)
  • Severe claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FDG-NaF-MRI

All participants will undergo three project scans/the following interventions:

FDG-PET-CT NaF-PET-CT Whole-body MRI All participants will undergo a whole-body x-ray as part of clinical routine practice.
Diagnostic test: FDG-PET-CT
scanning method
Diagnostic test: NaF-PET-CT
scanning method
Diagnostic test: Whole-body MRI
scanning method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone metastases detection rate - a patient-based analysis
Time Frame: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
To compare the proportion of patients with bone disease detected by the four scanning techniques
The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
Bone metastases detection rate - a region-based analysis
Time Frame: The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed
To compare the number of affected regions with bone disease detected by the four scanning techniques
The three project scans will be performed once and as baseline scans within a maximum of 30 days from the performance of the whole-body x-ray. Image analyses and statistical tests will be done when all project scans have been performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAMP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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