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WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
Workpackage 02
Illustrated imaging manual
05/05/2012 Slide no 1
Confidential 転載禁止
ワークパッケージ 02
画像評価の図解マニュアル
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
Workpackage 02
Introduction to the main imaging concept
05/05/2012 Slide no 2
ワークパッケージ 02
画像評価の主なコンセプトの紹介
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02 – main imaging concept of the study
• Main imaging question of the WAKE-UP study: • Is a diffusion restriction (left) already visible in the FLAIR image (right)?
05/05/2012 Slide no 3
DWI FLAIRDWI FLAIR
WP 02 – WAKE-UP研究の画像評価の主なコンセプト ・WAKE-UP研究の画像評価の中心となる問題： ・DWI病変（左）が FLAIR画像（右）で既に視認できるか？
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
• The diffusion restriction (left) is not already visible in the FLAIR image (right), makingthe patient „FLAIR negative“
• Suitable for randomization in WAKE-UP
05/05/2012 Slide no 4
DWI FLAIRFLAIR
DWI FLAIR
WP 02 – FLAIR positive vs FLAIR negative
WP 02 – FLAIR陽性 vs FLAIR陰性 ・DWI病変（左）が FLAIR画像（右）ではまだ視認できないので、この患者を“FLAIR陰性”とする ・WAKE-UPの無作為割付に適している
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
• The diffusion restriction (left) is already visible in the FLAIR image (right), making thepatient „FLAIR positive“
• Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 5
DWI FLAIRFLAIRDWI
WP 02 – FLAIR positive vs FLAIR negative
WP 02 – FLAIR陽性 vs FLAIR陰性 ・DWI病変（左）が FLAIR画像（右）で既に視認できるので、この患者を“FLAIR陽性”とする ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02 – FLAIR positive vs FLAIR negative
• The diffusion restriction (left) is not already visible in the FLAIR image (right), makingthe patient „FLAIR negative“
• Suitable for randomization in WAKE-UP
05/05/2012 Slide no 6
T2* DWI FLAIRDWI FLAIR
WP 02 – FLAIR陽性 vs FLAIR陰性 ・DWI病変（左）が FLAIR画像（右）ではまだ視認できないので、この患者を“FLAIR陰性”とする ・WAKE-UPの無作為割付に適している
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
• The diffusion restriction (left) is already visible in the FLAIR image (right), making thepatient „FLAIR positive“
• Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 7
DWI FLAIRFLAIRDWI
WP 02 – FLAIR positive vs FLAIR negative
WP 02 – FLAIR陽性 vs FLAIR陰性 ・DWI病変（左）が FLAIR画像（右）で既に視認できるので、この患者を“FLAIR陽性”とする ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
Workpackage 02
Further inclusion and exclusion criteria
05/05/2012 Slide no 8
ワークパッケージ 02
試験対象を選択および除外するその他の基準
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- hemorrhage
• Hemorrhagic stroke (primary bleed instead of an ischemic stroke) left frontal.• Exclusion criterion for tPA and therefore not suitable for randomization in WAKE-UP
05/05/2012 Slide no 9
T2* DWI FLAIR
WP 02 - 出血 ・左前頭部の脳出血（脳梗塞ではなく脳出血） ・組織プラスミノーゲン活性化因子（tPA）の適応外基準に該当するため、WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- hemorrhage
• Scattered left MCA-territory ischemic stroke• multiple microbleeds seen on the T2* image are not necessarily an exclusion
criterion for tPA• Suitable for randomization in WAKE-UP (if the acute lesion isn‘t visible on FLAIR)
05/05/2012 Slide no 10
T2* DWI DWI
WP 02 - 出血 ・左中大脳動脈（MCA）領域に散在する脳梗塞 ・T2*画像で視認できる複数の微小出血は、必ずしも tPAの適応外基準ではない ・WAKE-UPの無作為割付に適している（DWI病変が FLAIRで視認できない場合）
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- large hemispheric stroke
• DWI lesion is mainly cortical yet encompassing more than 1/3 of the MCA-territory*• Not suitable for randomization in WAKE-UP
* This exclusion criterion also applies to strokes covering more than 1/2 ACA or 1/2 PCA vessel territory
05/05/2012 Slide no 11
DWI FLAIR
WP 02 – 広範囲脳梗塞 ・DWI病変が主に皮質であるが MCA領域の 1/3を超える範囲に及ぶ* ・WAKE-UPの無作為割付に適さない *この除外基準は、前大脳動脈（ACA）領域の 1/2または後大脳動脈（PCA）領域の 1/2を超える範囲に広がる脳卒中に対しても適用される。
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- large hemispheric stroke
• Bad quality images due to patient movement, however DWI lesion covering much more than1/3 of the MCA-territory
• Not suitable for randomization in WAKE-UP
* This exclusion criterion also applies to strokes covering more than 1/2 ACA or 1/2 PCA vessel territory
05/05/2012 Slide no 12
T2* DWI FLAIR
*
WP 02 – 広範囲脳梗塞 ・患者の体動のため画質は悪いが、DWI 病変が MCA 領域の 1/3 を大幅に超える範囲に広がる* ・WAKE-UPの無作為割付に適さない *この除外基準は、ACA領域の 1/2または PCA領域の 1/2を超える範囲に広がる脳梗塞に対しても適用される。
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- image quality
• Right-sided MCA-territory ischemic stroke• Bad quality images (both DWI and FLAIR) due to patient movement• Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 13
DWI FLAIR
WP 02 - 画質 ・右側 MCA領域の脳梗塞 ・患者の体動のため画質が悪い（DWIおよび FLAIR両方） ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- motion artifacts
• Right-sided, basal ganglia and corona radiata (MCA-territory) ischemic stroke• DWI lesions appear in the area of extensive artifacts on the FLAIR image, making
visibility difficult to judge in a reliable fashion• Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 14
FLAIRDWI
WP 02 - 体動アーチファクト ・右基底核および放射冠（MCA領域）の脳梗塞 ・DWI病変は FLAIR画像でアーチファクトの影響が大きい領域にあり、視認性を確実に判断することが困難である ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- motion artifacts
• Left-sided, MCA-territory ischemic stroke including the basal ganglia• Although there are considerable motion artifacts in the area of the DWI lesions, these are
clearly visible on the FLAIR image. In addition, every second FLAIR image doesn‘t sufferfrom motion artifacts due to the interleaved nature of the image acquisition (making FLAIR lesion visibility reliable to judge).
• Not suitable for randomization in WAKE-UP (due to FLAIR positivity, not motion artifacts)
05/05/2012 Slide no 15
DWI DWIFLAIR FLAIR
WP 02 - 体動アーチファクト ・左基底核を含む MCA領域の脳梗塞 ・DWI病変の領域にかなりの体動アーチファクトがあるが、FLAIR画像でこれらの病変をはっきりと視認できる。さらに、撮像方法がインターリーブ方式なので FLAIR画像の 2枚に 1枚は体動アーチファクトの影響を受けない（FLAIR病変の視認性を確実に判断できるものにする） ・WAKE-UP の無作為割付に適さない（体動アーチファクトのためではなく、FLAIR 陽性のため）
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- leukaraiosis
• Scattered right, mostly subcortical MCA-territory ischemic stroke• DWI lesions appear in the area of extensive leukaraiosis and an old lacunar stroke,
making visibility difficult to judge in a reliable fashion• Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 16
DWI DWIFLAIR FLAIR
WP 02 - 白質病変 ・右 MCA領域に散在する、主に皮質下の脳梗塞 ・DWI病変は、広範な白質病変および陳旧性ラクナ梗塞のある領域にあり、視認性を確実に判断することが困難である ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- leukaraiosis
• Right-sided MCA-territory ischemic stroke• Although the DWI lesion appears in the area of leukaraiosis, large portions of the
lesion are outside the white matter changes making FLAIR visibility reliable to judge• Suitable for randomization in WAKE-UP
05/05/2012 Slide no 17
DWI FLAIR
WP 02 - 白質病変 ・右 MCA領域の脳梗塞 ・DWI病変は白質病変の領域にあるが、病変の大部分が白質変化の外側にあり、FLAIRの視認性を確実に判断できる ・WAKE-UPの無作為割付に適している
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- FLAIR negative / FLAIR positive
• Right-sided, mostly cortical MCA-territory ischemic stroke• The tissue signal in the right operculum and insula appears exactly the same as
contralateral, no lesion visibility on the FLAIR• Suitable for randomization in WAKE-UP
05/05/2012 Slide no 18
DWI FLAIR
WP 02 - FLAIR陰性／FLAIR陽性 ・右 MCA領域の主に皮質の脳梗塞 ・右弁蓋および島の組織の信号は反対側と全く同じであり、FLAIRで視認できる病変はない ・WAKE-UPの無作為割付に適している
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- FLAIR negative / FLAIR positive
• Right-sided, purely subcortical MCA-territory ischemic stroke, not visible in the FLAIR• If the clinical deficit is significant enough for inclusion into WAKE-UP, a purely
subcortical stroke on imaging is _not_ an exclusion criterion• Suitable for randomization in WAKE-UP
05/05/2012 Slide no 19
DWI FLAIR
WP 02 - FLAIR陰性／FLAIR陽性 ・右 MCA領域の純粋な皮質下の脳梗塞で、FLAIRでは視認できない ・神経脱落症状（臨床症状）がWAKE-UPの選択基準に一致すれば、画像で脳梗塞が完全に皮質下にあることだけで除外対象にはならない。 ・WAKE-UPの無作為割付に適している
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- FLAIR negative / FLAIR positive
• Right-sided, mostly cortical MCA-territory ischemic stroke• With enough contrasting many lesions can become subtly visible in the FLAIR.
WAKE-UP imaging criteria discourage aggressive contrasting. Under the currentcontrast settings, there is no lesion visibility on the FLAIR
• Suitable for randomization in WAKE-UP
05/05/2012 Slide no 20
DWI DWIFLAIR FLAIR
WP 02 - FLAIR陰性／FLAIR陽性 ・右 MCA領域の主に皮質の脳梗塞 ・コントラストを十分に高めることで、FLAIRで多くの病変をかすかに視認できるようになる。WAKE-UP の画像評価基準では、コントラストを著しく高めることを勧めない。現状のコントラスト設定において、FLAIRで視認できる病変はない ・WAKE-UPの無作為割付に適している
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- FLAIR negative / FLAIR positive
• Right-sided MCA-territory ischemic stroke• With enough contrasting the insular ribbon becomes subtly visible in the FLAIR.
However, without aggressive contrasting, there is no clear lesion visibility on theFLAIR
• Suitable for randomization in WAKE-UP
05/05/2012 Slide no 21
DWI FLAIR
WP 02 - FLAIR陰性／FLAIR陽性 ・右 MCA領域の脳梗塞 ・コントラストを十分に高めることで、FLAIRで島皮質をかすかに視認できるようになる。しかし、コントラストを著しく高めない限り、FLAIRではっきりと視認できる病変はない ・WAKE-UPの無作為割付に適している
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- FLAIR negative / FLAIR positive
• Right-sided MCA-territory ischemic stroke• Even with very mild contrasting the DWI lesion is visible in the FLAIR. • Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 22
DWI FLAIR
WP 02 - FLAIR陰性／FLAIR陽性 ・右側 MCA領域の脳梗塞 ・緩やかなコントラストでも、FLAIRで DWI病変を視認できる ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- FLAIR negative / FLAIR positive
• Right PCA-territory stroke (visible in the FLAIR) and a mostly cortical left-sidedMCA-territory stroke (clearly not visible in the FLAIR) signaling that this is a time distributed event
• If any acute ischemic lesion is visible in the FLAIR, the patient is considered „FLAIR positive“
• Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 23
DWI DWIFLAIR FLAIR
WP 02 - FLAIR陰性／FLAIR陽性 ・右 PCA領域の脳梗塞（FLAIRで視認できる）および左MCA領域の主に皮質の脳梗塞（FLAIRでは明らかに視認できない）があることから、異なる発症時刻の脳梗塞であると示唆される ・いかなる急性の虚血性病変でも FLAIRで視認できる場合は、患者を“FLAIR陽性”であると見なす ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
WP 02- FLAIR negative / FLAIR positive
• Left-sided MCA-territory stroke. • Higher cortical slices showing lesions which are visible in the FLAIR (G. frontalis
medius, postcentralis and angularis) whereas lower slices (insula and temporal lobe) are clearly not yet visible in the FLAIR) signaling that this is a time distributed event
• If any segment of the acute ischemic lesion is visible in the FLAIR, the patient isconsidered „FLAIR positive“
• Not suitable for randomization in WAKE-UP
05/05/2012 Slide no 24
DWI DWIFLAIR FLAIR
WP 02 - FLAIR陰性／FLAIR陽性 ・左 MCA領域の脳梗塞 ・上方の皮質スライスでは FLAIRで視認できる病変がある（中前頭回、中心後回および角回）一方で、下方のスライス（島および側頭葉）では明らかに FLAIRでまだ視認できないことから、異なる発症時刻の脳梗塞であると示唆される ・急性脳梗塞巣のいかなる部分でも FLAIRで視認できる場合は、患者を“FLAIR陽性”であると見なす ・WAKE-UPの無作為割付に適さない
WAKE-UP is funded by the European Commissionwithin the 7th Framework Programme
Illustrated imaging manualContacts:
05/05/2012 Slide no 25
Priv. Doz. Dr. med. Jochen B. FiebachHead of Academic NeuroradiologyCenter for Stroke Research Berlin (CSB)Charité - Universitätsmedizin BerlinCampus Benjamin FranklinHindenburgdamm 30D 12200 BerlinTel. +49 (0)30 8445 4088Email. [email protected]
Dr. med. MSc Ivana GalinovicStroke MRI GroupCenter for Stroke Research Berlin (CSB)Charité – Universitätsmedizin BerlinCampus Benjamin Franklin Hindenburgdamm 30D 12200 BerlinTel. +49 (0)30 8445 4174Email. [email protected]
Workpackage 02
