手術中の肺がん患者のがん検出におけるパニツムマブ-IRDye800
外科的処置中に肺がんを検出するための光学イメージング剤としてのパニツムマブ-IRDye800 の安全性と薬物動態を評価する第 I/II 相試験
This phase I/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To determine the optimal dose and timing of panitumumab IRDye800 infusion for identifying lung cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of the panitumumab IRDye800 as an imaging agent in subjects undergoing resection of lung cancer.
II. Determine whether the primary lung tumor or positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with panitumumab IRDye800 but not by white light imaging.
OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.
Participants receive panitumumab- IRDye800 intravenously (IV) over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days.
After completion of study treatment, participants are followed up for up to 30 days.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Natalie Lui
- 電話番号：650-721-2086
- メール：natalielui@stanford.edu
研究場所
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California
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Palo Alto、California、アメリカ、94304
- 募集
- Stanford University, School of Medicine
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主任研究者：
- Natalie Lui
-
コンタクト：
- Natalie Lui
- 電話番号：650-721-2086
- メール：natalielui@stanford.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
- Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
- Hemoglobin ≥ 9 gm/dL
- White blood cell count > 3000/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 1.5 times upper reference range
Exclusion Criteria:
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding
- Magnesium or potassium lower than the normal institutional values
- Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Prisoners, institutionalized individuals, and patients unable to consent for themselves
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Diagnostic (panitumumab-IRDye800, surgery, NIR)
Participants receive panitumumab- IRDye800 IV over 60 minutes on day 0, and then undergo NIR and surgery within 1-5 days. |
Undergo surgery Undergo imaging
他の名前：
Given IV
他の名前：
Correlative studies
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tumor to background ratio (TBR), measured in ex vivo tissues
時間枠：Up to 1 year
|
The TBR is defined as the near-infrared fluorescence signal of tumor or lymph node tissue compared to normal adjacent tissue measured in ex vivo tissues. Outcomes will be reported as the TBR (mean) and standard deviation for each dose group and timing group (1-2 days or 3-5 days prior to surgery). |
Up to 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
臨床的に重要であり、治験薬に確実に、おそらく、またはおそらく関連すると判断されたグレード2以上のAEの数
時間枠：30日まで
|
30日まで
|
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Metastatic lesion detection by Panitumumab-IRDye800 versus standard assessments
時間枠：Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify metastatic lesions. Outcomes will be reported as the number of metastatic lesions detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
|
Tumor-positive lymph node detection by Panitumumab-IRDye800 versus standard assessments
時間枠：Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify tumor-positive lymph nodes. Outcomes will be reported as the number of tumor-positive lymph nodes detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
|
Residual disease detection by Panitumumab-IRDye800 versus standard assessments
時間枠：Up to 1 year
|
Intraoperative near-infrared fluorescence imaging with panitumumab-IRDye800 will be compared to conventional white light visualization and ex vivo histopathology methods to identify residual disease at resection margins. Outcomes will be reported as the number of positive-margins detected by both near-infrared fluorescence imaging and histopathology, and each method alone. |
Up to 1 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Natalie Lui、Stanford University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。