Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial

Официальное название

SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Electronic Health Record Review
  Ancillary studies
• Процедура Fluorescence Imaging
  Undergo fluorescence imaging
• Процедура Fluorescence-Guided Surgery
  Undergo FGS
• Препарат Indocyanine Green
  Given IV
• Другое Questionnaire Administration
  Ancillary studies
• Процедура Resection
  Undergo surgical resection

Первичные конечные точки

• Unexpected positive margin (UPM) rate [Срок оценки: At 6 months post-surgery]

Вторичные конечные точки (10)

• Intraoperative complications [Срок оценки: During surgical resection]
• Postoperative complications [Срок оценки: Up to 12 months]
• Length of index operation [Срок оценки: During surgical resection]
• Length of inpatient stay [Срок оценки: Through study completion, an average of 1 year]
• Recurrence [Срок оценки: Up to 12 months]
• Therapies [Срок оценки: Up to 12 months]
• Overall survival [Срок оценки: Up to 12 months]
• Quality of life [Срок оценки: Up to 12 months]
• Recovery following resection [Срок оценки: Up to 12 months]
• Surgical impact and decision making [Срок оценки: Immediately following surgical resection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT07650656 · 24374 · NCI-2026-03865 · 24374 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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