The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000761268
Ethics application status
Approved
Date submitted
26/08/2009
Date registered
2/09/2009
Date last updated
9/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Study comparing whole body magenetic resonance imaging (MRI) and bone scan in estimation of bone disease in multiple myeloma patients in correlation with disease outcome
Scientific title
Study comparing whole body magenetic resonance imaging (MRI) and Technetium-99-sestamibi scan in estimation of bone disease in multiple myeloma patients in correlation with disease outcome
Secondary ID [1] 251956 0
Nil
Universal Trial Number (UTN)
Trial acronym
BSM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
estimation of bone disease in multiple myeloma patients by MRI and Technetium-99-sestamibi scan 237370 0
Condition category
Condition code
Cancer 239694 239694 0 0
Myeloma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Technetium 99m-MIBI and whole body MRI scans will be studied at staging for newly diagnosed multiple myeloma and during follow-up of existing patients at every 3 monthly follow-up for a total of two years.

Technetium 99m-MIBI and whole body (magnetic resonance imaging) MRI scans will be studied at staging for newly diagnosed multiple myeloma and during follow-up of existing patients.

Technetium-99m (99mTc-sestamibi) has recently been proposed as a potential sensitive tool in early diagnosis of bone disease in multiple myeloma, as its increased uptake in the bone marrow has been reported as indicator of myeloma activity.

Whole body MRI will be performed according to the study of Baur-Melnyk et al., published in 2007. Technetium 99m-MIBI will be administered in intravenously; thereafter anterior and posterior whole body scans will be obtained, using a large field of view gamma camera equipped with a low-energy high resolution microcast collimator. A semiquantitative uptake score will be used and scintigraphic findings will be correlated with whole body MRI, clinical and laboratory data.

For each patient a recent whole body MRI study will be available at the time of 99mTc-MIBI and the results of both techniques will be evaluated.

Evaluation of Imaging Data
All images will be assessed by two expert radiologists (more than 10 years of experience in MRI and nuclear medicine. The skeleton will be divided into 61 regions. Every region will be evaluated in a as presence of lytic lesion (yes or no) for myeloma involvement. In MRI, myeloma involvement will be determined according to the published criteria for focal or diffuse disease. Focal myeloma involvement is defined as a focal area of low signal intensity on T1-weighted spin-echo images which will be found in the bone marrow corresponding to high signal intensity on STIR images consistent with focal accumulation of myeloma cells. Diffuse infiltration is defined as diffusely reduced signal on T1-weighted spin-echo images and increased on STIR images in the bone marrow and will be graded as low, intermediate or high grade.
Intervention code [1] 237022 0
Not applicable
Comparator / control treatment
For each patient a recent whole body MRI study will be available at the time of 99mTc-MIBI and the results of both techniques will be evaluated by two expert radiologists and nuclear medicine physcians. Both scans will be performed prospectively in this study
Control group
Active

Outcomes
Primary outcome [1] 240463 0
To detect the rate and extent of skeletal events in myeloma patients on whole body (WB)-MRI, Technetium-99-sestamibi compared to conventional x-rays for the staging and follow up of patients with newly diagnosed and existing multiple myeloma.
Timepoint [1] 240463 0
whole body Magnetic resonance imaging (MRI) and Technetium-99-sestamibi scan at diagnosis and follow up of multiple myeloma at every 3 monthly follow-up for a total of two years.
Secondary outcome [1] 244996 0
The results of both scans will be analysed in terms of staging myeloma disease compared to conventional x-rays. They will also will be evaluated with disease outcome and prognosis.
Timepoint [1] 244996 0
At the time fo diagnosis and during follow up at every 3 monthly follow-up for a total of two years.

Eligibility
Key inclusion criteria
Adult patients who are 18 years and above with confirmed diagnosis of multiple myeloma according to the Salmon and Durie/World Health Organization (WHO) criteria and attending for treatment at the Launceston General Hospital
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients without bone involvement

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 237540 0
Hospital
Name [1] 237540 0
Launceston General Hospital
Address [1] 237540 0
Charles Street
Launceston
TAS 7250
Country [1] 237540 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles Street
Launceston
TAS 7250
Country
Australia
Secondary sponsor category [1] 237020 0
University
Name [1] 237020 0
University of Tasmania
Address [1] 237020 0
Charles Street
Launceston
TAS 7250
Country [1] 237020 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239536 0
Health and Medical Office of Research Services
Ethics committee address [1] 239536 0
University of Tasmania
Private Bag 01
HOBART TAS 7001
Ethics committee country [1] 239536 0
Australia
Date submitted for ethics approval [1] 239536 0
Approval date [1] 239536 0
18/08/2009
Ethics approval number [1] 239536 0
H0010634

Summary
Brief summary
Multiple myeloma is a common blood cancer that affects mainly elderly people with a current trend to affect younger patients from both sexes as well. This disease mainly affects the bones and causes in late stages a permanent bone damage and fractures. This bone damage becomes worse and irreversible if there is a delay in diagnosis or treatment of myeloma occurs.

To date, in Australia and worldwide convential x-rays are used to diagnose bone disease commonly associated with myeloma (about 80% of cases). However this technique is insensitive in prediction or detection of bone damage. It can be replaced by more sensitive techniques like whole body MRI, which we know little about it in conjunction with diagnosing bone disease in myeloma patients. Fortunately enough the MRI scan is now available at the Launceston General Hospital (LGH). More recently another nuclear scan technique called Sestamibi bone scan, also available at the LGH, developed to detect bone disease in cancer and may have a promising role in myeloma disease.

Currently, there is no data available to compare both above techniques in early detection and diagnosis of bone disease associated with myeloma blood cancer.

This trial offers a comparison between these methods in addition to other myeloma markers for early detection of bone disease. Furthermore establishing a reliable sensitive method compared to current standards for early detection of bone disease will enable clinicians to commence the appropriate treatment to prevent a devastating consequence of myeloma with bone fractures that disable many patients, who are suffering from this dreadful cancer.
Trial website
Trial related presentations / publications
Khalafallah AA, Snarski A, Heng R, Hughes R, Renu S, Arm J, Dutchke R, Robertson IK, To LB. Assessment of whole body MRI and sestamibi technetium-99m bone marrow scan in prediction of multiple myeloma disease progression and outcome: a prospective comparative study. BMJ Open. 2013 Jan 10;3(1). pii: e002025. doi: 10.1136/bmjopen-2012-002025. PMID: 23315438.

http://www.ncbi.nlm.nih.gov/pubmed/23315438
http://bmjopen.bmj.com/content/3/1/e002025.full.pdf+html
Public notes

Contacts
Principal investigator
Name 29973 0
Prof Alhossain Khalafallah
Address 29973 0
Launceston General Hospital,

Charles Street, Launceston, TAS 7250

Country 29973 0
Australia
Phone 29973 0
+61367776777
Fax 29973 0
Email 29973 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 13220 0
Prof Alhossain Khalafallah
Address 13220 0
Pathology Dept
Launceston General Hospital
Charles Street
Launceston, TAS 7250
Country 13220 0
Australia
Phone 13220 0
+61363487111
Fax 13220 0
+61363487695
Email 13220 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 4148 0
Prof Alhossain Khalafallah
Address 4148 0
Department of Pathology
Launceston general Hospital
Charles Street
Launceston
TAS 7250
Country 4148 0
Australia
Phone 4148 0
+61363487111
Fax 4148 0
+61363487695
Email 4148 0
khalafallah@dhhs.tas.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary