NCT03338049

Brief Summary

This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

October 25, 2017

Last Update Submit

May 18, 2020

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Yield

    Diagnostic yield associated with either EMN-bronchoscopy or EMN-TTNA

    Up to one year post index procedure

Secondary Outcomes (4)

  • Serious Adverse Events

    30 days post index procedure

  • Adverse Events

    30 days post index procedure

  • Rate of procedure cancellation

    On procedure day

  • Procedural Factors

    Intra-procedure

Study Arms (1)

Veran System

OTHER

Staged biopsy sampling methodology. If lymph node staging is negative, EMN-bronchoscopy will be performed. If EMN-bronchoscopy is negative, EMN-TTNA will be performed

Device: Veran System

Interventions

Veran SystemDEVICE

Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration

Also known as: Veran SPiN Thoracic Navigation System SPiNPerc Kit
Veran System

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is ≥21 years old,
  • The patient has a lung nodule identified on chest CT and is a candidate for elective EMN bronchoscopic evaluation as determined by the treating pulmonologist,
  • The size of the target nodule, as measured at its greatest diameter, is between 1-3cm,
  • Staging at the time of enrollment indicates NO/N1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum),
  • The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (\>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,
  • The patient has a lack of bleeding disorders, and
  • The patient is willing and able to provide informed consent.

You may not qualify if:

  • The patient is pregnant as confirmed by urine or serum pregnancy testing,
  • The patients has a body mass index (BMI) \>40,
  • There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Banner University Medical Center - Phoenix

Phoenix, Arizona, 85006, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina Medical Center

Charleston, South Carolina, 29425, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Publications (3)

  • Thiboutot J, Pastis NJ, Akulian J, Silvestri GA, Chen A, Wahidi MM, Gilbert CR, Lin CT, Los J, Flenaugh E, Semaan R, Burks AC, Sathyanarayan P, Wu S, Feller-Kopman D, Cheng GZ, Alalawi R, Rahman NM, Maldonado F, Lee HJ, Yarmus L. A Multicenter, Single-Arm, Prospective Trial Assessing the Diagnostic Yield of Electromagnetic Bronchoscopic and Transthoracic Navigation for Peripheral Pulmonary Nodules. Am J Respir Crit Care Med. 2023 Oct 15;208(8):837-845. doi: 10.1164/rccm.202301-0099OC.

    PMID: 37582154DERIVED

  • Mallow C, Lee H, Oberg C, Thiboutot J, Akulian J, Burks AC, Luna B, Benzaquen S, Batra H, Cardenas-Garcia J, Toth J, Heidecker J, Belanger A, McClune J, Osman U, Lakshminarayanan V, Pastis N, Silvestri G, Chen A, Yarmus L. Safety and diagnostic performance of pulmonologists performing electromagnetic guided percutaneous lung biopsy (SPiNperc). Respirology. 2019 May;24(5):453-458. doi: 10.1111/resp.13471. Epub 2019 Jan 24.

    PMID: 30675961DERIVED

  • Thiboutot J, Lee HJ, Silvestri GA, Chen A, Wahidi MM, Gilbert CR, Pastis NJ, Los J, Barriere AM, Mallow C, Salwen B, Dinga MJ, Flenaugh EL, Akulian JA, Semaan R, Yarmus LB. Study Design and Rationale: A Multicenter, Prospective Trial of Electromagnetic Bronchoscopic and Electromagnetic Transthoracic Navigational Approaches for the Biopsy of Peripheral Pulmonary Nodules (ALL IN ONE Trial). Contemp Clin Trials. 2018 Aug;71:88-95. doi: 10.1016/j.cct.2018.06.007. Epub 2018 Jun 7.

    PMID: 29885373DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lonny Yarmus, DO

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 9, 2017

Study Start

February 14, 2018

Primary Completion

October 29, 2019

Study Completion

December 1, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(9)