- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03745690
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
Phase 1B/2, Open-Label Study Evaluating Safety and Efficacy of Enhanced Permeability and Retention Effect for Near-Infrared Image Guided Surgical Resection of Head and Neck Cancers With Indocyanine Green
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.
SECONDARY OBJECTIVES:
I. Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.
OUTLINE:
Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.
After completion of study treatment, patients are followed up for 14-30 days.
연구 유형
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy.
- Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
- Planned standard of care surgery with curative intent for squamous cell carcinoma.
- Have life expectancy of more than 12 weeks.
- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1.
- Hemoglobin >= 9 gm/dL.
- White blood cell count > 3000/mm^3.
- Platelet count >= 100,000/mm^3.
- Serum creatinine =< 1.5 mg/dL.
- Liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin) =< 1.5 times the upper reference range.
- Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.
- Agree to not have radioactive iodine uptake studies done within 1 week of indocyanine green.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Allergy to iodine or iodinated materials.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Treatment (near-infrared image guided surgical resection)
Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
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Undergo near-infrared image guided surgical resection
Given IV
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
기간: Up to 30 days
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Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
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Up to 30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Successful tumor fluorescence imaging data gathered for all patients included in the study
기간: Up to 30 days
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The effect of indocyanine green will be assessed by changes in tumor-to-background ratio (TBR).
Tumor to background (TBR) data will be generated from still images collected throughout the procedure as previously described (Heath, Deep et al.).
The presence of fluorescence in normal surrounding tissue will be correlated with fluorescence within the tumor mass.
The linear relationship between fluorescence and tumor size will be computed as Spearman?s
correlation coefficient.
Continuous variable means (e.g., fluorescence intensity) will be compared to histological quantification of tumor as measured by the greatest dimension identified on the histopathological assessment.
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Up to 30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Abie Mendelsohn, UCLA / Jonsson Comprehensive Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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