Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial

Overview

Información sobre este estudio

The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • 18 years of age.
  • Suspected or tissue proven lung tumor and/or malignant peripheral/hilar lymph nodes.
  • Nodule size in CT between 8mm and 30 mm (largest dimension).
  • Ability to understand and willingness to sign a written informed consent and HIPAA consent document.

Exclusion Criteria:

  • Inability or non-willingness to provide informed consent.
  • Inability to comply with the study protocol.
  • Patients with known allergy for fluorescein or risk factors for an allergic reaction.
  • Use of beta-blocker within 24 hours before start of the bronchoscopic procedure.
  • Possible pregnant or lactating women.
  • Known allergy to fluorescein.
  • Patients with hemodynamic instability. 
  • Patients with refractory hypoxemia. 
  • Patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure.
  • Patients who are unable to tolerate general anesthesia according to the anesthesiologist.
  • Patient undergoing chemotherapy.                            
  • Pregnant or breast feeding.

Intra-operative Exclusion/Stopping Criteria:

  • The lesions are unable to be localized/confirmed by bronchoscopy.
  • The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician.
  • The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician.

Eligibility last updated 8/16/21.  Questions regarding updates should be directed to the study team contact.

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Janani Reisenauer, M.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Thoracic Surgery Research Unit

(877) 526-9172

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Sebastian Fernandez-Bussy, M.D.

Abierto para la inscripción

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publicaciones

Publications are currently not available
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CLS-20536824

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