Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
17 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
22
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
California
-
Duarte, California, États-Unis, 91010
- Recrutement
- City of Hope Medical Center
-
Contact:
- Thinzar Lwin
- Numéro de téléphone: 626-218-3880
- E-mail: tlwin@coh.org
-
Chercheur principal:
- Thinzar Lwin
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Arm I (standard of care)
Patients undergo standard of care surgical resection.
|
Etudes annexes
Subir une résection chirurgicale
Autres noms:
Etudes annexes
|
|
Expérimental: Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery.
Patients then undergo FGS with intraoperative fluorescence imaging.
|
Etudes annexes
Etudes annexes
Subir une imagerie par fluorescence
Étant donné IV
Autres noms:
Undergo FGS
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Unexpected positive margin (UPM) rate
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intraoperative complications
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Thinzar Lwin, City of Hope Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 mai 2027
Achèvement primaire (Estimé)
11 mai 2028
Achèvement de l'étude (Estimé)
11 mai 2028
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
12 juin 2026
Première publication (Réel)
16 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs par type histologique
- Tumeurs, tissus conjonctifs et mous
- Sarcome
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Techniques d'investigation
- Techniques et procédures de diagnostic
- Diagnostic
- Indoles
- Imagerie diagnostique
- Vert indocyanine
- Imagerie optique
Autres numéros d'identification d'étude
- 24374 (Autre identifiant: City of Hope Medical Center)
- P30CA033572 (Subvention/contrat des NIH des États-Unis)
- NCI-2026-03865 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .