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

12. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

22

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Duarte, California, Forente stater, 91010
        • City of Hope Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Thinzar Lwin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm I (standard of care)
Patients undergo standard of care surgical resection.
Annen: Spørreskjemaadministrasjon
Hjelpestudier
Fremgangsmåte: Reseksjon
Gjennomgå kirurgisk reseksjon
Andre navn:
  • Kirurgisk reseksjon
Annen: Gjennomgang av elektronisk helsejournal
Hjelpestudier
Eksperimentell: Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
Annen: Spørreskjemaadministrasjon
Hjelpestudier
Annen: Gjennomgang av elektronisk helsejournal
Hjelpestudier
Fremgangsmåte: Fluorescensavbildning
Gjennomgå fluorescensavbildning
Legemiddel: Indocyanin grønn
Gitt IV
Andre navn:
  • ICG
Fremgangsmåte: Fluorescence-Guided Surgery
Undergo FGS
Andre navn:
  • FGS
  • Fluorescens-veiledet kirurgisk prosedyre

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Unexpected positive margin (UPM) rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intraoperative complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

City of Hope Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Thinzar Lwin, City of Hope Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. mai 2027

Primær fullføring (Antatt)

11. mai 2028

Studiet fullført (Antatt)

11. mai 2028

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 24374 (Annen identifikator: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH-stipend/kontrakt)
  • NCI-2026-03865 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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