JP4607859B2 - 蛍光分析物と連動して作動するインビボ蛍光センサ、システム及び関連方法 - Google Patents
蛍光分析物と連動して作動するインビボ蛍光センサ、システム及び関連方法 Download PDFInfo
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- A61K49/00—Preparations for testing in vivo
- A61K49/001—Preparation for luminescence or biological staining
- A61K49/0013—Luminescence
- A61K49/0017—Fluorescence in vivo
- A61K49/0019—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules
- A61K49/0021—Fluorescence in vivo characterised by the fluorescent group, e.g. oligomeric, polymeric or dendritic molecules the fluorescent group being a small organic molecule
- A61K49/0041—Xanthene dyes, used in vivo, e.g. administered to a mice, e.g. rhodamines, rose Bengal
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- A—HUMAN NECESSITIES
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- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0071—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by measuring fluorescence emission
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- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
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- A61K49/001—Preparation for luminescence or biological staining
- A61K49/0013—Luminescence
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Description
本出願は、2003年2月19日に提出された「In Vivo Fluorescence Sensors,Systems,and Related Methods Operating in Conjunction with Fluorescently Labeled Materials」と題する米国仮特許出願第60/448,349号及び2003年5月19日に提出された「In Vivo Fluorescence Sensors,Systems,and Related Methods Operating in Conjunction with Fluorescently Labeled Materials」と題する米国仮特許出願第60/471,706号に対する優先権を主張するものであり、上記に挙げた文書の内容全体は参照して本明細書に組み込まれる。
W1<2R/tan(90−T) 方程式(1)
(式中、W1=断面図における検出器の幅、R=円筒形センサ本体の半径、T=フィルタの最大受光角)である。
R/tan(90−T) 方程式(2)
(式中、Rはセンサ本体の半径であり、Tはフィルタの臨界角である)より小さいように構成できる。そこで、上記のように、特定の実施形態では、Tは約15〜30度の範囲に及んでよい。そこで、検出器の長さLdは、15度については<0.27R、又は30度については<0.58Rであろう。フィルタ80cは、典型的にはその下にある検出器75の長さより長い長さを有し、全周囲を被覆する、又はアキシアル距離で終了する、又はセンサの本体の1つ以上の端部分より短い。
(1)BT474−超臨床レベルのHER2/neuを過剰発現する。
(2)MCF7−HER2/neuを発現しない。
(3)MCF7TamR−Duke大学でDr.Dewhirst,Blackwell及びDr.McDonnellによって開発された。これは、臨床的に重要なレベルでHER2/neuを過剰発現する。
Claims (27)
- 被験者(ヒトを除く)における治療法のインビボ臨床有効性を決定する方法であって、
身体内に埋め込まれるのに適合するセンサから、少なくとも1つの励起光信号を、前記少なくとも1つのセンサの近位の組織へ放射させるステップと、
前記被験者の対象領域内の蛍光に対応する信号を前記少なくとも1つのセンサからインビボで検出するステップと、
前記検出された信号を被験者の身体の外部の場所へ中継するステップと、及び
前記投与された蛍光前標識した分析物、自然蛍光分析物及び/又は被験者内にあると蛍光を示す分析物に対する前記被験者の局所的蛍光反応を決定するために経時的に信号をモニタリングするステップと、を含む方法。 - 前記励起光が約20mmまで離れている組織に浸透することができ、そして前記標識が約665から約695nmの波長の蛍光反応を生成する約630から約660nmの励起波長である、請求項1に記載の方法。
- 前記励起光が約20mmまで離れている組織に浸透することができ、そして前記標識が約400から約695nmの蛍光反応波長を生成する約400から約660nmの励起波長である、請求項1に記載の方法。
- 前記少なくとも1つのセンサが約25cmまでの表面下深さで身体内に埋め込まれるのに適合する、請求項1に記載の方法。
- 前記少なくとも1つの励起光信号が出力強度における所定変動を有する複数の信号を含み、そして前記検出された蛍光を使用して光学的プロファイリングデータが生成される、請求項1に記載の方法。
- 投与された遺伝子療法の結果として生じるタンパク質の発現を決定するために前記モニタリングするステップが実行される、請求項1に記載の方法。
- 前記モニタリングするステップに基づいて前記蛍光分析物に対する表現型反応を決定するステップをさらに含む、請求項1に記載の方法。
- 前記モニタリングするステップが前記蛍光分析物に対する癌細胞の感受性又は受容性を決定するステップを含む、請求項1に記載の方法。
- 検出された蛍光信号に結び付いたデータを使用して、(a)埋め込まれたセンサの近位で受容された分析物の濃度又は用量を計算するステップと、(b)前記蛍光分析物の薬力学的又は薬物動態学的活性を評価するステップと、(c)腫瘍部位へのAb付着を確認するステップと、(d)治療により過度に影響を受けていないことを確認するために非標的部位をモニタリングするステップと、(e)細胞特性の変化をモニタリングするステップと、(f)計算された用量又は濃度データを使用して前記被験者に投与される蛍光分析物の治療量を調整又はカスタマイズするステップと、(g)標的部位でのミセル濃度を確認し、次にその確認に基づいて毒素放出を刺激するステップと、及び(h)遺伝子療法による組み換えから生じたタンパク質の発現をモニタリングするステップと、のうちの少なくとも1つを実施するステップと、をさらに含む請求項1に記載の方法。
- 体内に投与された蛍光分析物と関連する被験者における蛍光を検出するための検出システムであって、前記蛍光分析物が蛍光体標識分析物、自然蛍光分析物及び前記被験者の体内に投与されると蛍光を示す分析物のうちの少なくとも1つを含み、前記検出システムが、インビボ作動のために構成された少なくとも1つの蛍光センサであって、前記少なくとも1つのセンサが、少なくとも間欠的に、蛍光分析物の投与後少なくとも約24時間に及ぶ期間にわたって励起光信号を放射し、放射された励起光信号に反応した身体内の局所組織内の蛍光分析物からの蛍光を検出するように構成されているセンサと、及び
励起信号の出力を方向付けて前記少なくとも1つのセンサから検出された蛍光に結び付いている蛍光強度信号データを受信するように構成された少なくとも1つのセンサと機能的に結び付いているプロセッサであって、前記プロセッサが少なくとも1つのモニタリング期間にわたって複数の時点に標的局所組織内の蛍光分析物の取り込み及び残留の1つ以上と結び付いた強度を経時的にモニタリングするためのコンピュータプログラムコードを含むプロセッサと、を含む検出システム。 - コンピュータプログラムコードが、前記モニタリングを行い、前記複数の時点に標的局所組織内の蛍光分析物の蛍光強度を連続的に決定し、そして次に前記蛍光分析物に対する薬物動態学的、薬力学的、生体動力学的反応及び/又は対象領域内の組織内の生物活性を決定するためのものである請求項10に記載のシステム。
- 前記少なくとも1つのセンサが個別に作動可能であるように構成された複数のセンサであり、そして前記プロセッサが各1つへ個別的にポーリングするように構成されている、請求項10に記載のシステム。
- 前記少なくとも1つのセンサを包み込む筋膜層と、約50〜100ミクロンの厚さを有する線維芽細胞とのいずれか一方又は両方を通過する励起光を生成するように構成されている、請求項10に記載のシステム。
- 前記センサが約20mmまで離れている組織へ浸透できる励起光を生成するように構成されている、請求項10に記載のシステム。
- 前記センサが約400から約660nmの波長を有する励起光信号を生成するように構成されている、請求項10に記載のシステム。
- 前記センサが約400から約695nmの蛍光反応波長を検出するように構成されている、請求項15に記載のシステム。
- 前記センサが前記励起光を生成するように構成されているレーザダイオードを含み、該レーザダイオードがパルスレーザダイオードとして前記励起光を生成し、前記パルスレーザダイオードが約10Hzから約1KHzの間の周波数及び約1から約10%の負荷サイクルで作動させられる、請求項10に記載のシステム。
- 前記システムが出力における所定の段階的変動を有する複数の信号を生成するように構成されており、そしてそれに反応して生成される前記検出された蛍光を使用して光学的プロファイリングデータが生成される、請求項10に記載のシステム。
- 前記センサが身体内に埋め込まれるのに適合し、さらに検出器を含み、そして前記センサ本体が対象波長の蛍光と結び付いた光線が前記センサ本体の内部から前記検出器へ移動するのを選択的に許容するその壁の上に形成された円筒形光学フィルタを含む、請求項10に記載のシステム。
- 前記センサが、前記励起光が前記円筒形フィルタを通って前記センサ本体を出ていくのを許容するために前記レーザダイオードと整列した複合フィルタをさらに含む、請求項19に記載のシステム。
- 前記センサが、前記励起光が前記円筒形フィルタを通って前記センサ本体を出ていくのを許容するために前記レーザダイオードと整列した光ウィンドウをさらに含む、請求項19に記載のシステム。
- 前記センサが、蛍光が進入して約1.15Rから約0.54R(式中、「R」は前記センサ本体の断面の半径である)の幅を有する検出器と係合することを許容するように構成されており、前記円筒形フィルタが前記センサ本体の長さより短い長さにある前記センサ本体の周囲にわたって実質的に連続的に伸びている、請求項21に記載のシステム。
- 前記励起源がレーザダイオードを含み、前記検出器が光ダイオードを含み、前記センサ本体がガラス製センサカプセルであり、そして前記センサが内部反射を阻害するために前記検出器及びダイオードを封入しているガラスカプセルへレーザダイオード及び光ダイオードを結合させるために屈折率整合されているエポキシをさらに含む、請求項10に記載のシステム。
- 前記センサが第2検出器をさらに含み、前記第1検出器が、蛍光信号がそれを通過することを選択的に許容するフィルタと機能的に結び付いており、そして前記第2検出器が励起光信号を検出するように構成されており、そして前記第2検出器からのデータを使用して第1検出器からのデータが正規化される、請求項23に記載のシステム。
- 前記第1及び第2検出器が前記センサ本体内で、並列整列で保持される、請求項24に記載のシステム。
- 前記第1及び第2検出器が背中合わせ整列で保持される、請求項24に記載のシステム。
- 前記励起源が相違する励起波長及び/又は出力で作動する第1及び第2ダイオードレーザを含む、請求項10に記載のシステム。
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-
2004
- 2004-02-17 CA CA002516497A patent/CA2516497A1/en not_active Abandoned
- 2004-02-17 US US10/779,907 patent/US7510699B2/en not_active Expired - Fee Related
- 2004-02-17 AU AU2004214420A patent/AU2004214420A1/en not_active Abandoned
- 2004-02-17 WO PCT/US2004/005785 patent/WO2004075032A2/en active Search and Examination
- 2004-02-17 JP JP2006503890A patent/JP4607859B2/ja not_active Expired - Fee Related
- 2004-02-17 EP EP04711947A patent/EP1594551A2/en not_active Withdrawn
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2009
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2010
- 2010-06-25 US US12/823,858 patent/US20100298672A1/en not_active Abandoned
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AU2004214420A1 (en) | 2004-09-02 |
US20090180962A1 (en) | 2009-07-16 |
WO2004075032A3 (en) | 2005-04-14 |
WO2004075032A2 (en) | 2004-09-02 |
US7778695B2 (en) | 2010-08-17 |
US20100298672A1 (en) | 2010-11-25 |
US20040197267A1 (en) | 2004-10-07 |
JP2006520216A (ja) | 2006-09-07 |
US7510699B2 (en) | 2009-03-31 |
AU2004214420A2 (en) | 2004-09-02 |
EP1594551A2 (en) | 2005-11-16 |
CA2516497A1 (en) | 2004-09-02 |
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