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Diagnostic Imaging of Myeloma Bone Lesions (RAMP)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
FDG-PET-CT
NaF-PET-CT
Whole-body MRI
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma

Eligibility Criteria

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

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

Sites / Locations

  • Department of Radiology/Department of Nuclear Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FDG-NaF-MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Bone metastases detection rate - a patient-based analysis
To compare the proportion of patients with bone disease detected by the four scanning techniques
Bone metastases detection rate - a region-based analysis
To compare the number of affected regions with bone disease detected by the four scanning techniques

Secondary Outcome Measures

Full Information

First Posted
April 25, 2017
Last Updated
May 8, 2017
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03147326
Brief Title
Diagnostic Imaging of Myeloma Bone Lesions
Acronym
RAMP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDG-NaF-MRI
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
FDG-PET-CT
Intervention Description
scanning method
Intervention Type
Diagnostic Test
Intervention Name(s)
NaF-PET-CT
Intervention Description
scanning method
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole-body MRI
Intervention Description
scanning method
Primary Outcome Measure Information:
Title
Bone metastases detection rate - a patient-based analysis
Description
To compare the proportion of patients with bone disease detected by the four scanning techniques
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
Title
Bone metastases detection rate - a region-based analysis
Description
To compare the number of affected regions with bone disease detected by the four scanning techniques
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik S. Thomsen, Professor
Organizational Affiliation
Department of Radiology
Official's Role
Study Director
Facility Information:
Facility Name
Department of Radiology/Department of Nuclear Medicine
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diagnostic Imaging of Myeloma Bone Lesions

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