ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

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]

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]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/10/2009

Actual

1/01/2010

Date of last participant enrolment

Anticipated

Actual

31/01/2011

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]

Hospital

Name [1]

Launceston General Hospital

Address [1]

Charles Street
Launceston
TAS 7250

Country [1]

Australia

Primary sponsor type

Hospital

Name

Launceston General Hospital

Address

Charles Street
Launceston
TAS 7250

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Tasmania

Address [1]

Charles Street
Launceston
TAS 7250

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Medical Office of Research Services

Ethics committee address [1]

University of Tasmania
Private Bag 01
HOBART  TAS  7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/08/2009

Ethics approval number [1]

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

Prof Alhossain Khalafallah

Address

Launceston General Hospital,

Charles Street, Launceston, TAS 7250

Country

Australia

Phone

+61367776777

Fax

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

Alhossain Khalafallah

Address

Pathology Dept
Launceston General Hospital
Charles Street
Launceston, TAS 7250

Country

Australia

Phone

+61363487111

Fax

+61363487695

khalafallah@dhhs.tas.gov.au

Contact person for scientific queries

Name

Alhossain Khalafallah

Address

Department of Pathology
Launceston general Hospital
Charles Street
Launceston
TAS 7250

Country

Australia

Phone

+61363487111

Fax

+61363487695

khalafallah@dhhs.tas.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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