High Grade SarcomaPhase 2NCT07650656
Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
A Phase 2 study testing Electronic Health Record Review, Fluorescence Imaging and Fluorescence-Guided Surgery in people with High Grade Sarcoma and Sarcoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High Grade Sarcoma, Sarcoma
- What is being tested?
- Electronic Health Record Review, Fluorescence Imaging and Fluorescence-Guided Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2026to 17 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Thinzar Lwin, 626-218-3880, tlwin@coh.org
Thinzar Lwin
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- To determine the effect of FGS using ICG compared to the SoC over a 12-month period.
EXPLORATORY OBJECTIVE:
- 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.
- Conditions
- High Grade Sarcoma, Sarcoma
- Being tested
- Electronic Health Record Review, Fluorescence Imaging, Fluorescence-Guided Surgery, Indocyanine Green, Questionnaire Administration
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Fluorescence ImagingProcedure or surgery
Undergo fluorescence imaging
Fluorescence-Guided SurgeryProcedure or surgery
Also called FGS, Fluorescence-Guided Surgical Procedure
Undergo FGS
Indocyanine GreenDrug
Also called ICG
Given IV
Questionnaire AdministrationOther
Ancillary studies
ResectionProcedure or surgery
Also called Surgical Resection
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard of care) | Active comparator | Patients undergo standard of care surgical resection. Receives: 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. Receives: Other: Electronic Health Record Review; Procedure: Fluorescence Imaging; Procedure: Fluorescence-Guided Surgery; Drug: Indocyanine Green; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months post-surgery
Secondary outcomes (10)
Intraoperative complications
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.
Measured: During surgical resection
Postoperative complications
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.
Measured: Up to 12 months
Length of index operation
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.
Measured: During surgical resection
Length of inpatient stay
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.
Measured: Through study completion, an average of 1 year
Recurrence
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.
Measured: Up to 12 months
Therapies
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.
Measured: Up to 12 months
Overall survival
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.
Measured: Up to 12 months
Quality of life
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.
Measured: Up to 12 months
Recovery following resection
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.
Measured: Up to 12 months
Surgical impact and decision making
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.
Measured: Immediately following surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start14 Aug 2026
- Primary completion17 Dec 2029 (estimated)
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade SarcomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thinzar Lwin, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650656
- Sponsor's protocol ID
- 24374
- Other IDs
- NCI-2026-03865, 24374, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SarcoSIGHT: A Randomized-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care
- ClinicalTrials.gov ID
- NCT07650656
- Acronym / sponsor ID
- 24374
- Conditions
- High Grade Sarcoma, Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- 17 Dec 2029 (estimated)
- Study completion
- 17 Dec 2029 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- To determine the effect of FGS using ICG compared to the SoC over a 12-month period.
EXPLORATORY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard of care) | Active comparator | Other: Electronic Health Record Review, Other: Questionnaire Administration, Procedure: ResectionPatients undergo standard of care surgical resection. |
| Arm II (FGS) | Experimental | Other: Electronic Health Record Review, Procedure: Fluorescence Imaging, Procedure: Fluorescence-Guided Surgery, Drug: Indocyanine Green, Other: Questionnaire AdministrationPatients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Arm I (standard of care), Arm II (FGS) |
| Fluorescence ImagingUndergo fluorescence imaging | Procedure or surgery | Arm II (FGS) |
| Fluorescence-Guided SurgeryAlso: FGS, Fluorescence-Guided Surgical ProcedureUndergo FGS | Procedure or surgery | Arm II (FGS) |
| Indocyanine GreenAlso: ICGGiven IV | Drug | Arm II (FGS) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (standard of care), Arm II (FGS) |
| ResectionAlso: Surgical ResectionUndergo surgical resection | Procedure or surgery | Arm I (standard of care) |
Primary outcome
Unexpected positive margin (UPM) rate
Time frame: 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.
10 secondary outcomes
Intraoperative complications
Time frame: During surgical resection
Postoperative complications
Time frame: Up to 12 months
Length of index operation
Time frame: During surgical resection
Length of inpatient stay
Time frame: Through study completion, an average of 1 year
Recurrence
Time frame: Up to 12 months
Therapies
Time frame: Up to 12 months
Overall survival
Time frame: Up to 12 months
Quality of life
Time frame: Up to 12 months
Recovery following resection
Time frame: Up to 12 months
Surgical impact and decision making
Time frame: Immediately following surgical resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for High Grade Sarcoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Osteosarcoma, Pediatric Osteosarcoma
RecruitingPhase 2
Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma
Soft Tissue Sarcoma
RecruitingObservational study
Treatment Patterns and Survival Outcomes in High-Grade Osteosarcoma: A Multicenter Retrospective Study
High-Grade Osteosarcoma
Active, not recruiting
PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer
Endometrial Clear Cell Adenocarcinoma, Endometrial Mixed Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thinzar Lwin principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electronic Health Record Review, Fluorescence Imaging and Fluorescence-Guided Surgery in people with High Grade Sarcoma and Sarcoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected positive margin (UPM) rate (time frame: At 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.