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Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma

2026년 9월 13일 업데이트: Washington University School of Medicine

Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma

This observational study will examine how closely first-window indocyanine green (ICG) fluorescence corresponds to the extent of head and neck squamous cell carcinoma identified by tissue biopsy. ICG is a fluorescent dye given into a vein during surgery. Patients receive ICG as part of their clinical care, independently of whether they participate in this study. The study plans to enroll 25 adults undergoing surgery for confirmed or strongly suspected cancer. Researchers will record near-infrared images obtained during clinical ICG use, compare them with tissue pathology, and measure the strength, timing, and duration of fluorescence. The research analysis will not guide clinical or surgical decisions. Participants will be followed through 24 hours after surgery.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

25

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Bharat Panuganti, MD, FACS
  • 전화번호: 314-362-7522
  • 이메일: bharatp@wustl.edu

연구 장소

  • 미국
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • Washington University School of Medicine
        • 연락하다:
        • 수석 연구원:
          • Bharat Panuganti, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Adults with histologically or cytologically confirmed, or strong clinical suspicion of, head and neck squamous cell carcinoma who are preparing to undergo surgical resection at Washington University School of Medicine / Barnes-Jewish Hospital.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
의약품: Indocyanine green
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.
다른 이름들:
  • ICG
절차: Near-infrared fluorescence imaging
Continuous video from completion of the saline flush (T0) through 3 minutes after each bolus, using an FDA-cleared ICG-compatible NIR imaging system.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Tumor-to-background ratio (TBR)
기간: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)

2차 결과 측정

결과 측정
측정값 설명
기간
Sensitivity of Indocyanine Green (ICG) fluorescence for tumor detection
기간: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Specificity of Indocyanine Green (ICG) fluorescence for tumor detection
기간: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Time to first detectable tumor fluorescence
기간: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Time to peak tumor-to-background ratio
기간: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day
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.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day
Association between ICG dose and tumor-to-background ratio
기간: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
Association between ICG dose and fluorescence washout kinetics
기간: During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)
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.
During surgery, from completion of each post-ICG saline flush through 3 minutes after the flush, for three planned boluses (1 day)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Washington University School of Medicine

수사관

  • 수석 연구원: Bharat Panuganti, MD, FACS, Washington University School of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 31일

기본 완료 (추정된)

2028년 4월 30일

연구 완료 (추정된)

2028년 4월 30일

연구 등록 날짜

최초 제출

2026년 9월 13일

QC 기준을 충족하는 최초 제출

2026년 9월 13일

처음 게시됨 (실제)

2026년 9월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 13일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 202608227

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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