Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
2026年6月17日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
22
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
Duarte、California、美国、91010
- 招聘中
- City of Hope Medical Center
-
接触：
- Thinzar Lwin
- 电话号码：626-218-3880
- 邮箱：tlwin@coh.org
-
首席研究员：
- Thinzar Lwin
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm I (standard of care)
Patients undergo standard of care surgical resection.
|
辅助研究
接受手术切除
其他名称：
辅助研究
|
|
实验性的：Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery.
Patients then undergo FGS with intraoperative fluorescence imaging.
|
辅助研究
辅助研究
进行荧光成像
鉴于IV
其他名称：
Undergo FGS
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Unexpected positive margin (UPM) rate
大体时间：At 6 months post-surgery
|
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.
|
At 6 months post-surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intraoperative complications
大体时间：During surgical resection
|
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.
|
During surgical resection
|
|
Postoperative complications
大体时间：Up to 12 months
|
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.
|
Up to 12 months
|
|
Length of index operation
大体时间：During surgical resection
|
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.
|
During surgical resection
|
|
Length of inpatient stay
大体时间：Through study completion, an average of 1 year
|
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.
|
Through study completion, an average of 1 year
|
|
Recurrence
大体时间：Up to 12 months
|
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.
|
Up to 12 months
|
|
Therapies
大体时间：Up to 12 months
|
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.
|
Up to 12 months
|
|
Overall survival
大体时间：Up to 12 months
|
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.
|
Up to 12 months
|
|
Quality of life
大体时间：Up to 12 months
|
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.
|
Up to 12 months
|
|
Recovery following resection
大体时间：Up to 12 months
|
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.
|
Up to 12 months
|
|
Surgical impact and decision making
大体时间：Immediately following surgical resection
|
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.
|
Immediately following surgical resection
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Thinzar Lwin、City of Hope Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年5月15日
初级完成 (估计的)
2028年5月11日
研究完成 (估计的)
2028年5月11日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.