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

12. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

22

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • Duarte, California, Vereinigte Staaten, 91010
        • City of Hope Medical Center
        • Kontakt:
        • Hauptermittler:
          • Thinzar Lwin

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Arm I (standard of care)
Patients undergo standard of care surgical resection.
Sonstiges: Fragebogenverwaltung
Nebenstudien
Verfahren: Resektion
Unterziehe dich einer chirurgischen Resektion
Andere Namen:
  • Chirurgische resektion
Sonstiges: Überprüfung der elektronischen Patientenakte
Nebenstudien
Experimental: Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery. Patients then undergo FGS with intraoperative fluorescence imaging.
Sonstiges: Fragebogenverwaltung
Nebenstudien
Sonstiges: Überprüfung der elektronischen Patientenakte
Nebenstudien
Verfahren: Fluoreszenzbildgebung
Unterziehen Sie sich einer Fluoreszenzbildgebung
Arzneimittel: Indocyaningrün
Gegeben IV
Andere Namen:
  • IKG
Verfahren: Fluorescence-Guided Surgery
Undergo FGS
Andere Namen:
  • FGS
  • Fluoreszenzgesteuertes chirurgisches Verfahren

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Unexpected positive margin (UPM) rate
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intraoperative complications
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

City of Hope Medical Center

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Thinzar Lwin, City of Hope Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Mai 2027

Primärer Abschluss (Geschätzt)

11. Mai 2028

Studienabschluss (Geschätzt)

11. Mai 2028

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 24374 (Andere Kennung: City of Hope Medical Center)
  • P30CA033572 (US NIH Stipendium/Vertrag)
  • NCI-2026-03865 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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