Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

ENB Robotic ICG Guided Surgery: A Novel Technique for Targeting Small Lung Tumors (ENB-RIGGS)

1 juin 2017 mis à jour par: Wael Hanna, St. Joseph's Healthcare Hamilton

Robotic ICG Guided Surgery (RIGGS) Using Electromagnetic Navigational Bronchoscopy (ENB): A Novel Technique for Targeting Small Lung Tumors

Lung cancer is the leading cause of cancer deaths worldwide. However, if diagnosed at an early stage (tumor <2 cm), lung cancer is highly curable with a 5-year survival rate greater than 80% after surgical resection. Screening tests have made it easier to identify small lung tumors. However, these tumors are often not visible to the naked eye, and surgeons cannot feel them, making them difficult to precisely locate and remove. For this reason, surgeons have become more reliant on image guided surgery for the removal of these tumors.

The standard of care for locating and removing small lung tumors is microcoil-guided video-assisted thoracoscopic surgery (VATS). This is a two-step procedure performed by two separate physicians.

  • First, patient is taken to radiology suite and radiologist inserts a microcoil near the lung tumor
  • Second (usually occurs a few hours later), patient is taken to operating room; a surgeon uses an x-ray arm to find the microcoil within the lung and remove it surgically.

A pathologist reviews the resected tissue to make sure that the tumor and the microcoil were both removed. Until this evaluation, the surgeon does not know whether the tumor has been removed or not. While this method is safe, it is time consuming, uses staff resources, and requires bulky equipment to complete.

In this study, we plan to develop and test a new method of identifying and removing small lung tumors. This procedure is called Electromagnetic Navigational Bronchoscopy (ENB) Robotic Indocyanine Green Guided Surgery (RIGGS) or ENB-RIGGS for a short name. The purpose of this study is to test the safety and reliability of the ENB-RIGGS surgery in the form of a pilot study.

ENB-RIGGS surgery is done in the operating room by a surgeon under general anesthetic. ENB-RIGGS begins by creating a 3-D GPS map of the lung which guides the surgeon directly to the tumor. A fluorescent green dye called indocyanine green is then injected into the tumor, and when viewed by the special robotic camera the tumour will fluoresce with a green hue allowing the surgeon to easily see the tumour. The surgeon then uses the robot to remove the tumor and surrounding tissue. The lung tissue specimen will be evaluated immediately by a pathologist.

Aperçu de l'étude

Statut

Retiré

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Phase

  • La phase 1

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Age > 18 years
  2. Peripheral lung tumour that is <2 cm in size on a CT scan
  3. Fit to undergo thoracic surgery as assessed by the surgeon.

Exclusion Criteria:

  1. Hypersensitivity or allergy to ICG, sodium iodide or iodine
  2. Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.

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: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Indocyanine green
Médicament: Indocyanine Green
In the operating room ENB will be used to locate the targeted lung tumor. Once the tumor is located, the surgeon will advance a bronchoscope to the tumor, a needle will be passed through the bronchoscope, and the tumor will be injected with 100-150 micro liters of ICG solution at 0.125mg/mL concentration. The tumor is expected to fluoresce using the da Vinci Firefly robotic camera, giving off a bright green hue. Wedge resection of the fluorescent part of the lung will then be performed. The excised specimen will be sent for immediate pathologist analysis. If the tumor is found within the specimen, and the specimen margins are free of tumor cells, then the procedure will be completed. If the tumor cannot be targeted or visualized, or if the tumor is not found in the pathological specimen, or if the margins of the specimen contain tumor cells, then a formal anatomical lobectomy or segmental resection of the lung will be performed to ensure that the tumor is completely excised.
Autres noms:
  • IC-VERT

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Safety determined by the rates of adverse reactions to ICG dye, intra-operative adverse events, and post-operative complications as defined by the Ottawa Thoracic Morbidity and Mortality classification
Délai: Post-operatively, an average of 2 years
Post-operatively, an average of 2 years
Reproducibility
Délai: Post-operatively, an average of 2 years
Reproducibility will be measured by the aggregate score on items 1-4 of the 6-item scale which include: targeting of tumor on ENB (advance a bronchoscope to the targeted tumor); injection of the tumour with ICG; detection of ICG fluorescence with near-infrared light; wedge resection. The reproducibility score for each procedure will be the sum of the first 4 items on the 6-item scale and can range between 0/4 to 4/4. The reproducibility rate will be defined as the percentage of patients who score 4/4 on the reproducibility scale.
Post-operatively, an average of 2 years
Oncological validity
Délai: Post-operatively, an average of 2 years
The oncological validity score for each procedure will be the sum of the last 2 items on the 6-item scale (ex-vivo localization of tumor; ex-vivo confirmation of tumour-free margins) and can range between 0/2 to 2/2. The oncological validity rate will be defined as the percentage of patients who score 2/2 on the oncological validity scale.
Post-operatively, an average of 2 years

Mesures de résultats secondaires

Mesure des résultats
Délai
Process Feasibility will be determined by recruitment rate (The proportion of patients enrolled in the study versus the number eligible, up to n=30)
Délai: pre-operatively, an average of 2 years
pre-operatively, an average of 2 years
Management Feasibility will be determined by the percentage of cases for which ICG was successfully obtained from pharmacy and prepared for the ENB-RIGGS procedure
Délai: pre-operatively, an average of 2 years
pre-operatively, an average of 2 years
Resource Feasibility will be determined by the sum of the dollar costs of the ENB-RIGGS materials and personnel required to perform the procedure, divided by the number of participants.
Délai: pre-operatively, an average of 2 years
pre-operatively, an average of 2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

St. Joseph's Healthcare Hamilton

Les enquêteurs

  • Chercheur principal: Waël C. Hanna, MDCM, MBA, FRCSC, St. Joseph's Healthcare Hamilton / McMaster University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 (Anticipé)

1 octobre 2017

Achèvement primaire (Anticipé)

1 octobre 2017

Achèvement de l'étude (Anticipé)

1 octobre 2017

Dates d'inscription aux études

Première soumission

6 octobre 2015

Première soumission répondant aux critères de contrôle qualité

6 octobre 2015

Première publication (Estimation)

7 octobre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2017

Dernière vérification

1 juin 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BFCRS-RP-002-1504-29

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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 .

S'abonner