Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
2026년 6월 12일 업데이트: City of Hope Medical Center
SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care
This phase II trial compares standard of care surgical resection to fluorescence-guided surgical resection using indocyanine green and fluorescence imaging for reducing unexpected positive margin rates in patients with sarcoma.
Surgical margins are one of the criteria used in assessing the effectiveness of a given surgical procedure.
They are the edges or border of the tissue removed in cancer surgery.
A negative margin means that the resected tumor is surrounded by normal tissue, which implies there is no disease left in the patient.
By contrast, a positive margin means that sarcoma cells are visible at the edge of the tumor.
Positive margins may be classified as planned when they are expected pre-operatively due to the preservation of a critical structure, or unexpected when the pathologist reports the presence of tumor at the margin despite the surgeon having intended to remove it in its entirety.
Fluorescence-guided surgery is an established surgical method that involves the administration of fluorescent dye (in this case, indocyanine green) into the tumor, which can then be visualized with a special camera during surgery to help surgeons identify tumor versus healthy tissue.
Fluorescence-guided surgery may reduce the rate of unexpected positive margins in patients undergoing surgery for sarcoma.
연구 개요
상태
아직 모집하지 않음
상세 설명
PRIMARY OBJECTIVE:
I. To determine whether there is a reduction in the unexpected positive margin rate (UPM) in patients receiving fluorescence-guided surgery (FGS) using indocyanine green (ICG) compared to standard of care (SoC).
SECONDARY OBJECTIVE:
I. To determine the effect of FGS using ICG compared to the SoC over a 12-month period.
EXPLORATORY OBJECTIVE:
I. To determine the role of ICG in the pathological margin assessment of resected sarcoma specimens whilst improving understanding of the cellular mechanisms of FGS using ICG.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care surgical resection.
ARM II: Patients receive ICG intravenously (IV) 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
연구 유형
중재적
등록 (추정된)
22
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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연락하다:
- Thinzar Lwin
- 전화번호: 626-218-3880
- 이메일: tlwin@coh.org
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수석 연구원:
- Thinzar Lwin
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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
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Documented written informed consent of the participant
- Histologically confirmed diagnosis of intermediate to high grade sarcoma
- All ages
- Amenable to surgical resection as a part of curative intent for the patient
Willingness to:
- Respond to surveys during the trial
- Permit medical record/ clinical laboratory result review
Exclusion Criteria:
- Due for surgery with palliative intent
- Recurrent tumors
- Intracranial, retroperitoneal, and visceral anatomical locations
- A woman of childbearing potential who is currently pregnant (as confirmed by urine pregnancy test)
- A woman who are currently breastfeeding
- Known allergies to ICG, iodine, iodine dyes or shellfish
- Unable to provide written and informed consent
- Patients with hyper-thyroidism or autonomic thyroid adenomas
- Premature infants/neonates with exchange transfusion indication due to hyperbilirubinemia
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Arm I (standard of care)
Patients undergo standard of care surgical resection.
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보조 연구
수술적 절제술을 받다
다른 이름들:
보조 연구
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실험적: Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery.
Patients then undergo FGS with intraoperative fluorescence imaging.
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보조 연구
보조 연구
형광 이미징 진행
주어진 IV
다른 이름들:
Undergo FGS
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Unexpected positive margin (UPM) rate
기간: At 6 months post-surgery
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The margin status of each tumor will be taken from the pathology report for each patient enrolled in the trial.
This will be recorded at six months post- surgery and will be classified according to the R classification system.
The UPM rate for each arm will be defined by calculating the percentage of patients in that arm with a UPM on histopathological assessment of the resection specimen.
The percentage of patients with unexpected positive margins will be calculated for each group to give the unexpected positive margin rate.
This will then be compared between the two groups.
Will use a logistic regression that adjusts key covariates including stratification factors used in the randomization.
A Wald test and a 95% confidence interval will be extracted from this model.
A two-sided p-value will be found from the Wald test.
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At 6 months post-surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intraoperative complications
기간: During surgical resection
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Intraoperative complications may include blood loss requiring transfusion, inadvertent damage to nerves, inadvertent damage to tendons/ligaments, inadvertent damage to bony structures, myocardial infarction, stroke, other events determined by the principal investigator to be a complication of the surgery.
Will be compared between the two groups at the day of operation.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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During surgical resection
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Postoperative complications
기간: Up to 12 months
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Postoperative complications may include wound infection, wound dehiscence, seroma, flap complications, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, other events determined by the principal investigator to be a complication of the surgery.
Post operative complications will be graded using the Calvien Dindo Classifications of Surgical Complications.
Will be compared between the two groups at the day of operation and at 1-, 6- and 12-month follow-up time points.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Up to 12 months
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Length of index operation
기간: During surgical resection
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Will be measured in minutes.
Will be compared between groups on the day of operation.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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During surgical resection
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Length of inpatient stay
기간: Through study completion, an average of 1 year
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Will be measured in days.
Will be compared between the two groups at the day of operation and at 1-, 6- and 12-month follow-up time points.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Through study completion, an average of 1 year
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Recurrence
기간: Up to 12 months
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Local/regional/distal recurrence is defined as the recurrence of sarcoma at the site of primary resection (local) or at a site other than that of the primary tumor, including distal metastasis.
Investigations must be tailored to circumstances but where possible should include histological confirmation.
Will be compared between the two groups at the 12-month time point.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Up to 12 months
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Therapies
기간: Up to 12 months
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Adjuvant and neo-adjuvant therapy rates will include radiation therapy and/or chemotherapy.
The type and frequency of therapy will be recorded.
Will be compared between groups on the day of operation.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Up to 12 months
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Overall survival
기간: Up to 12 months
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Overall survival is defined as death due to any cause.
Where possible, the specific cause of death should be documented, allowing the calculation of disease specific survival.
Will be compared between the two groups at the 12-month time point.
Descriptive analysis will be performed to analyze the nature of the data.
Survival analysis like the Kaplan-Meier statistics will be used to find the overall survival in each arm.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Up to 12 months
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Quality of life
기간: Up to 12 months
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Quality of life will be assessed using the EQ-5D-5L European Quality of Life Five Dimension Five Level scale or European Quality of Life Five Dimension Three Level Youth scale.
Will be compared between the two groups.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Up to 12 months
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Recovery following resection
기간: Up to 12 months
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After undergoing surgical resection for sarcomas of the extremity, participants are often left with an element of functional impairment in the affected limb due to the extent of the resection required.
There are separate questionnaires for participants undergoing surgery on the upper and lower extremities, in which participants are asked to rate their ability to perform several tasks, rating them from 'impossible' to 'not at all difficult', as well as overall rating of how disabled they feel they are.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Up to 12 months
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Surgical impact and decision making
기간: Immediately following surgical resection
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Immediately following the surgical procedure, a surgical case report form (CRF) will be completed by the surgeon who performed the surgery.
This CRF will record if there was the potential for an acceptable close/positive margin due to the preservation of a critical structure, the length of the operation and any intra-operative complications.
If the participant was randomized to the intervention arm, the CRF will also record whether the surgeon felt this influenced their operative decision making.
Descriptive analysis will be performed to analyze the nature of the data.
Secondary outcomes with binary/multiple measures will be analyzed with logistic regression.
For variables with continuous measure, appropriate regression models will be used.
Appropriate statistical tests depending on the nature of the variables (whether qualitative or quantitative) will be used for comparison between the two treatment arms.
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Immediately following surgical resection
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Thinzar Lwin, City of Hope Medical Center
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)
2027년 5월 15일
기본 완료 (추정된)
2028년 5월 11일
연구 완료 (추정된)
2028년 5월 11일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 12일
처음 게시됨 (실제)
2026년 6월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 12일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 24374 (기타 식별자: City of Hope Medical Center)
- P30CA033572 (미국 NIH 보조금/계약)
- NCI-2026-03865 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
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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