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Linfadenectomia urológica em AMIGO

26 de setembro de 2026 atualizado por: Matthew Mossanen, MD, MPH, Brigham and Women's Hospital

Linfadenectomia guiada por imagem em regiões urológicas de interesse no AMIGO

This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, which will simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes).

The U.S. Food and Drug Administration (FDA) has not approved the navigation systems (3D Slicer and Monaco) as a treatment for any disease.

In this research study, our hypothesis is that the use of the navigation systems (3D Slicer and the Siemens Monaco system) may simplify the complexity of laparoscopic lymphadenectomy (The procedure in which a small incision is made in the lower abdomen to reach the lymph nodes) in regions of urologic interest, by resulting in better visualization and more accurate localization of the diseased lymph node and allowing for improved surgical and patient outcomes, fewer complications, and better clinician performance.

The long-term goal of our program is to demonstrate that the navigation system (3D Slicer and the Siemens Monaco system) increase the efficiency and reduce the morbidity or the likelihood of any medical problems associated with the resection or removal of radiologically defined lesions, within urologic regions of interest, associated with any type of urologic cancer. The first clinical application of the system will be in resecting radiologically positive lymph nodes displayed by CT or FDG PET (an imaging test used to identify lymphomas and other cancers) in the Advanced Multimodality Image-Guided Operating (AMIGO) Suite at Brigham and Women's Hospital (BWH).

The navigation system has been used with similar protocols, specifically 5 parathyroid surgeries, 13 tracked endoscopic ultrasound (minimally invasive procedure to assess digestive and lung diseases) and over 30 tracked colonoscopy experiments (exam used to detect changes or abnormalities in the large intestine (colon) and rectum) on human subjects at BWH with no difficulties or reportable incidents.

It will take you up to 4 weeks to complete this study. During that time you will have two study visits and one standard of care follow-up visit.

The research study procedures include: screening for eligibility and study treatment including evaluations and standard of care follow-up visits.

It is expected that about 20 people will take part in this research study.

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

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.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Recrutamento
        • Brigham and Women's Hospital
        • Investigador principal:
          • Matthew Mossanen, MD
        • Contato:

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
  • Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy.
  • Subjects must have had a CT, PET or MR examination of acceptable quality at Brigham and Women's Hospital within the prior month.
  • Subjects must also be scheduled to undergo lymphadenectomy for a urologic cancer within the following urologic regions of interest: Bladder, Prostate, Testicular, Kidney, Urethral, and Penile.
  • Subjects must also be scheduled to undergo a laparoscopic lymphadenectomy within the AMIGO OR

Exclusion Criteria:

  • Severely impaired renal function with an EGFR < 30 mL/min/body surface area
  • Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
  • History of hypersensitivity or other contraindication to contrast media
  • Contraindication to general anesthesia
  • Pregnancy

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: Diagnóstico
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Urologic Lymphadenectomy in AMIGO

Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
Dispositivo: 3D Slicer

Navigational device used during surgery to locate abnormal lymph nodes.

Dispositivo: Monaco

Navigational device used during surgery to locate abnormal lymph nodes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of Patients Completing Intended Procedure (Feasibility)
Prazo: One month, up to 45 days after registration

The Slicer-Monaco prototype navigation platform will be used to resect enlarged and/or fluorodeoxyglucose avid lymph nodes. The successful navigational use of this platform will be considered as completed. The proportion of patients completing this intended procedure will be reported.
One month, up to 45 days after registration

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of Patients with Laparoscopic Videos Recorded
Prazo: One month, up to 45 days from registration

During the first phase of the project on 10 patients, we will store real-time laparoscopic videos using the KARL STORZ 3D Video system that can be analyzed offline. During the second phase of 10 patients, we will provide an optional video overlay option in the navigation system. The navigation system will be similar to that used on the first 10 patients. The only difference will be that the virtual endoscopy view will be overlaid on the laparoscopy video in the 3D Slicer navigation system.
One month, up to 45 days from registration
Path length Kinematic Metric
Prazo: One month, up to 45 days after registration

The kinematic metric of path length will be computed using recorded data from the navigation system. Mean path length scores for all patients will be reported for each kinematic measure.
One month, up to 45 days after registration
Velocity Kinematic Metric
Prazo: One month, up to 45 days after registration

The kinematic metric of velocity will be computed using recorded data from the navigation system. Mean velocity scores for all patients will be reported for each kinematic measure.
One month, up to 45 days after registration
Acceleration Kinematic Metric
Prazo: One month, up to 45 days after registration

The kinematic metric of acceleration will be computed using recorded data from the navigation system. Mean acceleration scores for all patients will be reported for each kinematic measure.
One month, up to 45 days after registration
Jerk Kinematic Metric
Prazo: One month, up to 45 days after registration

The kinematic metric of jerk will be computed using recorded data from the navigation system. Mean jerk scores for all patients will be reported for each kinematic measure.
One month, up to 45 days after registration
Mental/Physical/Temporal Demand on Physician
Prazo: One month, up to 45 days after registration

The mental, physical and temporal demand on physicians will be assessed using the NASA Task Load Index (NASA-TLX), a multidimensional assessment tool that rates perceived workload in order to assess the performance of a task. The NASA task load index has a scoring range of 1 to 10 for mental demand, physical demand, temporal demand, effort, and frustration with 1 representing a very low value and 10 representing a very high value. A mean score out of 10 will be given for each operation and a mean score for all 20 operations will be given (out of 10). Assessment will be filled out by investigators.
One month, up to 45 days after registration
Mean absolute difference in distance from Instruments to Organs
Prazo: One month, up to 45 days after registration

The accuracy of localization of the organs will be quantified by pointing to specific structures and evaluating the distance of the registered instrument from the structures in the image space.
One month, up to 45 days after registration
Further, the pathology of the lymph node resected using the navigation system will be compared to the other lymph nodes resected in urologic regions of interest.
Prazo: One month, up to 45 days after registration

To ensure quality control of the procedure, the lymph node removed with the navigation system will be compared to the other lymph nodes resected in urologic regions of interest without the use of the navigation system.

The unit of measure will be the accuracy of targeting the PET-avid lymph node as confirmed by pathology, i.e., binary decision variable for two categories (using the navigation system or not). Using the navigation system: malignant or not, versus not using with the navigation system: malignant or not. The measurement tool will be the pathological analysis.
One month, up to 45 days after registration

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Brigham and Women's Hospital

Investigadores

  • Investigador principal: Matthew Mossanen, MD, Brigham and Women's Hospital

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 (Real)

1 de abril de 2022

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de novembro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de novembro de 2021

Primeira postagem (Real)

24 de novembro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de setembro de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 21-372

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Prazo de Compartilhamento de IPD

Data can be shared no earlier than 1 year following the date of publication

Critérios de acesso de compartilhamento IPD

Contact the Partners Innovations team at http://www.partners.org/innovation

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

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

Sim

produto fabricado e exportado 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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