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

NCT07650656 | Recruiting Phase 2 DMC

• 3 other identifiers: 24374NCI-2026-03865P30CA033572
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

High Grade Sarcoma; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Unexpected positive margin (UPM) rate

  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

Secondary Outcomes (10)

• 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

Study Arms (2)

Arm I (standard of care)

ACTIVE COMPARATOR

Patients undergo standard of care surgical resection.

Other: Electronic Health Record Review; Other: Questionnaire Administration; Procedure: Resection

Arm II (FGS)

EXPERIMENTAL

Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.

Other: Electronic Health Record Review; Procedure: Fluorescence Imaging; Procedure: Fluorescence-Guided Surgery; Drug: Indocyanine Green; Other: Questionnaire Administration

Interventions

Fluorescence Imaging PROCEDURE

Undergo fluorescence imaging

Arm II (FGS)

Fluorescence-Guided Surgery PROCEDURE

Undergo FGS

Also known as: FGS, Fluorescence-Guided Surgical Procedure

Arm II (FGS)

Indocyanine Green DRUG

Given IV

Also known as: ICG

Arm II (FGS)

Questionnaire Administration OTHER

Ancillary studies

Arm I (standard of care); Arm II (FGS)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (standard of care); Arm II (FGS)

Resection PROCEDURE

Undergo surgical resection

Also known as: Surgical Resection

Arm I (standard of care)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Optical Imaging; Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Thinzar Lwin

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): May 15, 2027
• Primary Completion (Estimated): May 11, 2028
• Study Completion (Estimated): May 11, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)