Fluorescence-Guided Surgical Resection for Reducing Unexpected Positive Margins in Patients With Sarcoma, SarcoSIGHT Trial
12 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
22
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
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Contato:
- Thinzar Lwin
- Número de telefone: 626-218-3880
- E-mail: tlwin@coh.org
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Investigador principal:
- Thinzar Lwin
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Arm I (standard of care)
Patients undergo standard of care surgical resection.
|
Estudos auxiliares
Submeta-se a ressecção cirúrgica
Outros nomes:
Estudos auxiliares
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Experimental: Arm II (FGS)
Patients receive ICG IV 12-24 hours prior to their scheduled surgery.
Patients then undergo FGS with intraoperative fluorescence imaging.
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Estudos auxiliares
Estudos auxiliares
Submeta-se a imagens de fluorescência
Dado IV
Outros nomes:
Undergo FGS
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Unexpected positive margin (UPM) rate
Prazo: 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.
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At 6 months post-surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intraoperative complications
Prazo: 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.
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During surgical resection
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Postoperative complications
Prazo: Up to 12 months
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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.
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Up to 12 months
|
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Length of index operation
Prazo: 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.
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During surgical resection
|
|
Length of inpatient stay
Prazo: 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.
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Through study completion, an average of 1 year
|
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Recurrence
Prazo: 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.
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Up to 12 months
|
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Therapies
Prazo: 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.
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Up to 12 months
|
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Overall survival
Prazo: 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.
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Up to 12 months
|
|
Quality of life
Prazo: 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.
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Up to 12 months
|
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Recovery following resection
Prazo: 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.
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Up to 12 months
|
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Surgical impact and decision making
Prazo: Immediately following surgical resection
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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.
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Immediately following surgical resection
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thinzar Lwin, City of Hope Medical Center
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de maio de 2027
Conclusão Primária (Estimado)
11 de maio de 2028
Conclusão do estudo (Estimado)
11 de maio de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de junho de 2026
Primeira postagem (Real)
16 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias de Tecidos Conjuntivos e Moles
- Sarcoma
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Técnicas de investigação
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Indoles
- Diagnóstico imagens
- Indocianina Verde
- Imagem óptica
Outros números de identificação do estudo
- 24374 (Outro identificador: City of Hope Medical Center)
- P30CA033572 (Concessão/Contrato do NIH dos EUA)
- NCI-2026-03865 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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