Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma
Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma
調査の概要
詳細な説明
This single-center, prospective observational cohort study evaluates the relationship between first-window ICG fluorescence and the biopsy-defined extent of head and neck squamous cell carcinoma during surgical resection. The decision to use intraoperative ICG is made as part of clinical care independently of study enrollment. Research activities consist of recording fluorescence imaging data and correlating those data with standard-of-care histopathology. First-window imaging captures fluorescence during initial dye perfusion after intraoperative administration.
After tumor exposure and standard white-light inspection, the ICG regimen described for observation consists of a 2 mg intravenous bolus followed by a saline flush. Completion of the flush defines T0. Continuous near-infrared video is recorded from T0 through 3 minutes after T0 using an ICG-compatible imaging system. The described regimen includes three boluses totaling 6 mg ICG; actual doses and administration times are documented. Clinical dosing decisions remain with the treating team independently of study participation. Further dosing may be held for hypersensitivity or hemodynamic instability, and imaging may be stopped if it interferes with surgical workflow.
Biopsies are obtained according to standard clinical practice, and their locations relative to fluorescence are documented. The research correlation of fluorescence with histopathology does not direct clinical or surgical decisions. Fluorescence measurements are compared with histopathology to estimate tumor-to-background ratio, sensitivity, specificity, time to fluorescence onset, time to peak contrast, and dose-dependent fluorescence dynamics. De-identified imaging data will be analyzed by the University of Alabama at Birmingham Department of Otolaryngology.
Participants are followed through 24 hours after surgery. Adverse events considered at least possibly related to ICG are collected from the first dose through 24 hours after surgery.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Bharat Panuganti, MD, FACS
- 電話番号：314-362-7522
- メール：bharatp@wustl.edu
研究場所
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Missouri
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St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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コンタクト：
- Bharat Panuganti, MD, FACS
- 電話番号：314-362-7522
- メール：bharatp@wustl.edu
-
主任研究者：
- Bharat Panuganti, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Histologically or cytologically confirmed, or strong clinical suspicion contingent on standard of care pre-operative assessment, of head and neck squamous cell carcinoma (HNSCC), preparing to undergo surgical resection.
- At least 18 years of age.
- The effects of ICG on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to surgery and for 1 week after surgery. Should a woman become pregnant or suspect she is pregnant during this time or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG, sodium iodide, or other agents used in the study.
- Thyroid radioactive uptake study within 1 week of ICG administration.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day of surgery.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Head and neck surgical resection cohort
Adults undergoing resection for confirmed or strongly suspected HNSCC who receive intraoperative ICG with NIR imaging as part of clinical care independently of study enrollment.
Research activities include recording imaging data and comparing fluorescence with routine tissue pathology.
The research analysis does not guide clinical or surgical decisions.
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Clinical exposure of interest: intraoperative ICG.
The regimen described for observation is three 2 mg IV boluses, each followed by a saline flush, totaling 6 mg.
Actual doses and times are recorded; clinical dosing is determined independently of study participation.
他の名前：
Continuous video from completion of the saline flush (T0) through 3 minutes after each bolus, using an FDA-cleared ICG-compatible NIR imaging system.
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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 |
|---|---|---|
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Tumor-to-background ratio (TBR)
時間枠：During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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TBR is calculated as the mean fluorescence intensity (MFI) within a region of interest (ROI) drawn over pathology-confirmed tumor tissue divided by the MFI within an ROI drawn over adjacent clinically normal tissue, as measured on intraoperative near-infrared fluorescence imaging.
The mean TBR with 95% confidence intervals will be reported.
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During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sensitivity of Indocyanine Green (ICG) fluorescence for tumor detection
時間枠：During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Defined as the proportion of histopathologically confirmed tumor regions correctly identified as fluorescent.
A standardized fluorescence ratio (SFR) threshold, determined by receiver operating characteristic (ROC) analysis using the maximum Youden's J index, will be used to classify tissue as fluorescent-positive or fluorescent-negative.
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During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Specificity of Indocyanine Green (ICG) fluorescence for tumor detection
時間枠：During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Defined as the proportion of histopathologically confirmed normal tissue regions correctly identified as non-fluorescent.
A standardized fluorescence ratio (SFR) threshold, determined by receiver operating characteristic (ROC) analysis using the maximum Youden's J index, will be used to classify tissue as fluorescent-positive or fluorescent-negative.
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During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Time to first detectable tumor fluorescence
時間枠：During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Time in seconds from completion of the saline flush after intravenous ICG administration (T0) to the first visible tumor fluorescence above background on serial intraoperative NIR imaging.
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During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Time to peak tumor-to-background ratio
時間枠：During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day
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Time in seconds from completion of the saline flush after intravenous ICG administration (T0) to the first visible tumor fluorescence above background on serial intraoperative NIR imaging.
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During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day
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Association between ICG dose and tumor-to-background ratio
時間枠：During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Association between administered ICG dose, expressed in mg/kg after adjustment for body weight, and tumor-to-background ratio (TBR), evaluated using Pearson or Spearman correlation.
TBR is the mean fluorescence intensity in pathology-confirmed tumor divided by that in adjacent clinically normal tissue.
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During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Association between ICG dose and fluorescence washout kinetics
時間枠：During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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Relationship between administered ICG dose and the decline in tumor-to-background ratio over time, characterized by fitting exponential decay models to serial TBR measurements.
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During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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協力者と研究者
捜査官
- 主任研究者：Bharat Panuganti, MD, FACS、Washington University School of Medicine
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 202608227
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