Guidelines for a standardized Guidelines for a standardized MRI protocol for MS:MRI protocol for MS:

Rationale for Standardized MRI

Applying knowledge from population studies to understanding the individual

Applying knowledge from population studies to understanding the individual

• Early diagnosis- “MS” • Monitoring subclinical

disease– activity & extent

• Monitoring treatment efficacy

• Identifying factors influencing prognosis

Clinical Threshold Line

Clinically Definite MS

Clinically Isolated Syndrome

Disease Onset

Early “MS” (Old Terminology)

Time

Relapsing MS

Progressive Stages

Classic MS

Clinically Isolated Syndrome

MS

Early Diagnosis of MS - New Criteria

For 5 mm /gapped slices median reported at 5 lesions

Formal evaluation 3mm non-gapped

slices median 13 lesions

Formal evaluation median 7

Clinically Isolated Syndrome + Positive MRIExperience and Technique Determine Result

Monitoring Subclinical Disease

This is what MRI is all about!

Most MS pathology is clinically silent

• Disease activity by MRI is 5-10 fold greater than clinical activity

• The reversible & irreversible accumulating BOD relatively clinically silent but may become important over time

Subclinical Pathological Events New + Enlarging T2 Lesion Profile

0

10

20

30

40

50

60

70

0 6 12 18

Time (months)

Num

ber

Les

ions

From Treatment Trials to Monitoring the Individual Patient ?

Phase III clinical trial data

Counting enhancing (or new T2) lesions to monitor an individualRichert et al, 2000

• Lesion detection, characterization - early diagnosis

• Detecting new lesions –patient management & treatment issues

• Lesion characterization - common terminology• Consistent reporting & charting of findings over

time

Advantages to standardization of MRI

in individuals:

Standardized MRI

Acquisition

StandardizedClinical Indicationsfor MRI &follow-upMRI

StandardizedInterpretation

of MRI

StandardizedCharting of

Disease Activity

Standardized MRI Protocol PRESCRIPTIVE GUIDELINES

Standardized MRI

Report

CMSC MRI Guidelines Meetings CMSC MRI Guidelines Meetings

Organizing Committee:Don Paty, Joe Frank, Pat Coyle, David Li, Jack Simon, Jerry Wolinsky, Tony Traboulsee

Participants:North American, NZ, and Europeanclinical and research MS Neurologists, Neuroradiologists and MRI Technologists

Representatives: RSNA,ASNR

• Consensus workshop in November 2001 sponsored by Consensus workshop in November 2001 sponsored by the CMSC. ( 35 participants)the CMSC. ( 35 participants)

Two working groups: one for the clinical guidelines Two working groups: one for the clinical guidelines and one for the standardized MRI protocol.and one for the standardized MRI protocol.

• Follow-up meeting in March 2003 to update the Follow-up meeting in March 2003 to update the guidelines and protocol.(19 participants)guidelines and protocol.(19 participants)

Objective for the MRI protocol:Objective for the MRI protocol:

What is a reasonable standardized What is a reasonable standardized clinical MRI protocol that will allow clinical MRI protocol that will allow comparison between studies?comparison between studies?

Objective for theObjective for the clinical guidelinesclinical guidelines:

When should MRI be performed to When should MRI be performed to diagnose and follow MS patients? diagnose and follow MS patients?

Guideline--Suspected MS Guideline--Suspected MS

When available, a brain MRI that meets the standardized When available, a brain MRI that meets the standardized protocol should be done as part of the initial protocol should be done as part of the initial evaluation and for diagnosisevaluation and for diagnosis

Indication for follow-up MRI in suspectedsuspected MS:

To establish the diagnosis of MS by detecting silent disease disseminated in time and/or space.

Indications for spinal MRI - 1:If the main presenting symptoms are at the level of the spinal

cord, and have not resolved, then a spinal cord MRI and brain MRI are recommended.

Indications for spinal MRI - 2:When the brain MRI gives equivocal results, spinal MRI provides

increased specificity in patients with an abnormal brain MRI or increased sensitivity in patients with a negative brain MRI.

The baseline evaluation of a patient with established MS includes a brain The baseline evaluation of a patient with established MS includes a brain MRI that meets the standardized protocol in addition to a MRI that meets the standardized protocol in addition to a comprehensive neurological history and examination.comprehensive neurological history and examination.

In the absence of clinical indications, routine follow-up MRI (at pre-defined intervals) in establishedestablished MS is not validated at this time, whether the patient is on disease modifying therapy or not.

Indications for follow-up MRI in establishedestablished MS include:

Re-assessment for initiation or modification of treatment.

Unexpected clinical worsening

Suspicion of a secondary diagnosis.

If a follow-up MRI is to be done, it should be performed by the If a follow-up MRI is to be done, it should be performed by the standardized MRI protocol and compared to previous studies.standardized MRI protocol and compared to previous studies.

Guidelines in Clinically Definite MS Guidelines in Clinically Definite MS

Regarding the use of gadolinium:Regarding the use of gadolinium:

Suspected MS – recommended.Suspected MS – recommended.If lesions are not seen on PD, T2 or flair If lesions are not seen on PD, T2 or flair sequences, then it may not be necessary to give sequences, then it may not be necessary to give gadolinium.gadolinium.

Baseline evaluation of established MS – Baseline evaluation of established MS – optional.optional.

Follow-up evaluation – optionalFollow-up evaluation – optional

It was generally agreed that gadolinium It was generally agreed that gadolinium provides useful additional information provides useful additional information about new, inflammatory activity.about new, inflammatory activity.

Standardized MRI Standardized MRI MethodologyMethodology

•1.0 Tesla or higher

• < 3 mm, no gap if possible; otherwise 5 mm, no gap•

Standardized MRI Standardized MRI MethodologyMethodology

•1.0 Tesla or higher

• < 3 mm, no gap if possible; otherwise 5 mm, no gap•

Sagittal FLAIR

FLFLuid uid AAttenuated ttenuated IInversion nversion RRecoveryecovery

SequencesSequences

AxialProton DensityProton Density

T2T2

FLAIRFLAIR

SequencesSequences

Conventional Spin Echo Conventional Spin Echo or Fast (Turbo) SEor Fast (Turbo) SE

**

Axial (Post) Gadolinium Enhanced T1

Pre-gadolinium Pre-gadolinium axial T1 scans are axial T1 scans are optionaloptional

IV Gadolinium IV Gadolinium 0.1mmol/kg 0.1mmol/kg (single dose) over (single dose) over 30 seconds30 seconds Minimum delay ofMinimum delay of5 minutes before5 minutes before scanning scanning

Brain MRI Protocols

Recommended

Recommended

Optional

Optional

Recommended

Recommended

Recommended

Recommended

Established MSBaseline or FU

Suspected MS Diagnosis

Gadoliniumenhanced T1

Axial FLAIR

Axial PD/T2

Sagittal FLAIR

Sequences

*Gadolinium may not be necessary if no lesions on the PD/T2 or FLAIR images

*

SpineSpine

No additional No additional gadolinium required if gadolinium required if spinal cord study spinal cord study immediately follows immediately follows Gad-enhanced brain Gad-enhanced brain MRIMRI

Slice thickness:Slice thickness: << 3 mm, no gap 3 mm, no gap

In plane resolution:In plane resolution: << 1mm x 1mm 1mm x 1mm

Spinal Cord MRI Protocol

Helpful to confirm suspicious lesions

Axial T2

For suspicious lesions

Through suspicious lesions

Axial post-gad T1

Sagittal post-gad T1

RecommendedSagittal pre-Gad T1

RecommendedSagittal PD/T2

Sequences

The referring physician should indicate on the request for the standardized MRI brain and/or spinal cord protocol (in addition to appropriate clinical information) one of the following indications:• Suspected MS• Baseline evaluation of MS• Follow-up of MS

Communication

The radiology report should use common language and include:• Description of findings

(lesion number, location, size, shape, character and qualitative assessment of brain atrophy)

Communication

An optional standardized reporting table may An optional standardized reporting table may be helpful to the radiologist and neurologist.be helpful to the radiologist and neurologist.

• Comparison with previous studies (new, enlarging and/or enhancing lesions, atrophy)

• Interpretation and Differential diagnosis

Standardized Reporting and Charting

Copies of these MRI studies should be retained permanently and be available.

Studies should be stored in a standard format (example DICOM).Studies should be stored in a standard format (example DICOM).

It may be useful for patients to keep their own studies on portable It may be useful for patients to keep their own studies on portable digital media.digital media.

Archival & Storage

Implementation strategiesImplementation strategies• Presentations at local and international Presentations at local and international

meetings.meetings.• Booth at annual meetings.Booth at annual meetings.• CME (use and interpretation training) – CME (use and interpretation training) –

Web or CD based.Web or CD based.• Manufacturer specific protocols.Manufacturer specific protocols.• Technologists web sites and newsletters.Technologists web sites and newsletters.• Improved access to CMSC website.Improved access to CMSC website.• Examples on website (lesions, subcallosal Examples on website (lesions, subcallosal

line, protocols).line, protocols).• Publications.Publications.

CMSC MRI GuidelinesCMSC MRI Guidelines

FutureFuture

The guidelines will need to The guidelines will need to be updated as new be updated as new information becomes information becomes availableavailable..

The guidelines have been presented at The guidelines have been presented at major international meetingsmajor international meetings