SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Unexpected positive margin (UPM) rate
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The histopathology staff and senior trial statistician will be blinded and unaware of the surgery type to allow for blinded measurement and analysis of primary outcome.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented written informed consent of the participant
- •Histologically confirmed diagnosis of intermediate to high grade sarcoma
- •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
排除标准
- •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
研究组 & 干预措施
Arm I (standard of care)
Patients undergo standard of care surgical resection.
干预措施: Electronic Health Record Review (Other)
Arm I (standard of care)
Patients undergo standard of care surgical resection.
干预措施: Resection (Procedure)
Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
干预措施: Questionnaire Administration (Other)
Arm I (standard of care)
Patients undergo standard of care surgical resection.
干预措施: Questionnaire Administration (Other)
Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
干预措施: Electronic Health Record Review (Other)
Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
干预措施: Fluorescence Imaging (Procedure)
Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
干预措施: Fluorescence-Guided Surgery (Procedure)
Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Unexpected positive margin (UPM) rate
时间窗: 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.
次要结局
- Intraoperative complications(During surgical resection)
- Postoperative complications(Up to 12 months)
- Length of index operation(During surgical resection)
- Length of inpatient stay(Through study completion, an average of 1 year)
- Recurrence(Up to 12 months)
- Surgical impact and decision making(Immediately following surgical resection)
- Therapies(Up to 12 months)
- Overall survival(Up to 12 months)
- Quality of life(Up to 12 months)
- Recovery following resection(Up to 12 months)