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Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing. (ARTEMIS)

29. juni 2026 opdateret af: Rafael Paez, Vanderbilt University Medical Center

Advanced Robotic Techniques and Rapid Onsite Evaluation for Minimally Invasive Diagnosis and Next-Generation Sequencing: the ARTEMIS Trial.

ARTEMIS is a multicenter randomized controlled trial. The goal is to understand whether rapid onsite evaluation during robotic assisted bronchoscopy improves the diagnostic performance of the procedure or not.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Pulmonary nodules are an incredibly common finding, with millions incidentally detected in the US every year. Biopsy is often needed for diagnosis. Robotic assisted bronchoscopy (RAB) with integrated cone beam computed tomography (CBCT) has achieved diagnostic yields exceeding 80% in some studies, significantly higher than traditional methods without advanced imaging, due to the added ability to correct alignment of the bronchoscopy catheter with the target lesion in real-time. Given this, the added value of rapid on-site cytologic evaluation (ROSE) with modern bronchoscopy is an area of debate. ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy. This study will aim to test the hypothesis that modern bronchoscopy done without ROSE guidance is non-inferior to bronchoscopy with ROSE available. Patients undergoing RAB to biopsy a lung lesion will be approached for enrollment and assigned to either ROSE vs no ROSE if they agree to participate. Randomization will be revealed before procedures are started. All decisions regarding procedure tools, techniques, and patient management will be per usual care and at the discretion of the treating physician.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
        • Ledende efterforsker:
          • James Katsis, MD
        • Kontakt:
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Memorial Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Christopher Kapp, MD
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University
        • Kontakt:
          • Jenna Loss Research coordinator
          • Telefonnummer: 410-955-5000
          • E-mail: jlos1@jhmi.edu
        • Ledende efterforsker:
          • Jeffrey Thiboutot, MD
    • Massachusetts
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Hospital and Medical Center
        • Ledende efterforsker:
          • Carla Lamb, MD
        • Kontakt:
    • New York
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan Kettering Cancer Center
        • Ledende efterforsker:
          • Lonny Yarmus, DO
        • Kontakt:
          • Shanti Persuad Research coordinator
          • Telefonnummer: 332-699-7260
          • E-mail: mangarl@mskcc.org
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27154
        • University of North Carolina Medical Center
        • Ledende efterforsker:
          • Jason Akulian, MD
        • Kontakt:
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
        • Ledende efterforsker:
          • Christopher Gilbert, MD
        • Kontakt:
          • Michael Balassone Research coordinator
          • Telefonnummer: 843-792-2300
          • E-mail: balassom@musc.edu
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Rafael Paez, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • ≥ 18 years of age at time of bronchoscopy
  • Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion

Exclusion Criteria:

  • Declines to participate or inability to provide informed consent.
  • Clinician determination that the use of ROSE is required or contraindicated for the optimal care of an individual patient
  • Patient enrolled in another trial that requires ROSE for PPL biopsy
  • Patient previously consented for this trial
  • Pregnant or incarcerated patients

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Robotic assisted bronchoscopy with ROSE
Participants allocated to the robotic assisted bronchoscopy arm with rapid onsite evaluation will have ROSE available during the procedure
Andet: Rapid onsite evaluation
ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy
Aktiv komparator: Robotic assisted bronchoscopy without ROSE
Participants allocated to the robotic assisted bronchoscopy arm without rapid onsite evaluation will not have ROSE available during the procedure
Andet: Rapid onsite evaluation
ROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Tidsramme: 7 days post procedure

Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified:

  1. Malignancy
  2. Specific benign pathologic findings including: organizing pneumonia, frank purulence/robust neutrophilic inflammation with a pathogen isolated, granulomatous inflammation, hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns.
7 days post procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sufficiency of malignant specimens for Next-Generation Sequencing
Tidsramme: 30 days post procedure
Proportion of malignant biopsies with sufficient material to send for NGS
30 days post procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt University Medical Center

Samarbejdspartnere

AstraZeneca

Efterforskere

  • Ledende efterforsker: Fabien Maldonado, MD, Vanderbilt University Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. april 2028

Studieafslutning (Anslået)

1. april 2029

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 260528

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results reported will be made available after de-identification.

IPD-delingstidsramme

The data will become available 3 months following publication of outcomes and will remain available for at least 3 years.

IPD-delingsadgangskriterier

Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rapid onsite evaluation

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Betingelser

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