NCT02978170

Brief Summary

This pilot clinical trial studies how well cone-beam computed tomography (CBCT) works in guiding bronchoscopy in patients with lung lesions. CBCT during bronchoscopy may help doctors to biopsy lung lesions that are harder to reach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

November 28, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

2.4 years

First QC Date

November 28, 2016

Last Update Submit

May 31, 2019

Conditions

Pulmonary Mass

Outcome Measures

Primary Outcomes (1)

  • Feasibility based on percentage of patients where researchers can locate target and bronchoscopic tools with cone-beam computed tomography

    Will be considered feasible if researchers can locate target and bronchoscopic tools with cone-beam computed tomography in at least 80% of the patients (16 out of the 20 participants) that are enrolled.

    Up to 6 months

Secondary Outcomes (5)

  • Proportion of patients with peripheral nodules undergoing bronchoscopy in different subsample

    Up to 6 months

  • Localization of the tip with respect to targets

    Up to 6 months

  • Diagnostic yield

    Up to 6 months

  • Amount of radiation generated by cone-beam computed tomography use

    Up to 6 months

  • Fluoroscopy/bronchoscopy time

    Up to 6 months

Study Arms (1)

Diagnostic (CBCT)

EXPERIMENTAL

Patients undergo CBCT during standard of care bronchoscopy.

Procedure: Cone-Beam Computed Tomography

Interventions

Cone-Beam Computed TomographyPROCEDURE

Undergo CBCT

Diagnostic (CBCT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing guided-bronchoscopy for diagnosis of peripheral lung lesion/s \> 1 and \< 3 cm in diameter located in the outer 2/3 of the lung fields

You may not qualify if:

  • Pregnant or breastfeeding women
  • Patient with indications for mediastinal lymph node (LN) sampling per 13th American College of Clinical Pharmacy (ACCP) guidelines
  • Patient with metastatic disease (from primaries other than lung) who have suspicious mediastinal or hilar LN that require sampling
  • Patients with contraindication/s for general anesthesia (e.g., severe and active coronary artery disease, chronic obstructive pulmonary disease \[COPD\] with forced expiratory volume in 1 second \[FEV1\] \< 1 liter, uncontrolled hypertension, increased intracranial pressure, history of intolerance to general anesthesia)
  • Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Casal RF, Sarkiss M, Jones AK, Stewart J, Tam A, Grosu HB, Ost DE, Jimenez CA, Eapen GA. Cone beam computed tomography-guided thin/ultrathin bronchoscopy for diagnosis of peripheral lung nodules: a prospective pilot study. J Thorac Dis. 2018 Dec;10(12):6950-6959. doi: 10.21037/jtd.2018.11.21.

    PMID: 30746241DERIVED

Related Links

Study Officials

  • Roberto Casal, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

November 28, 2016

Primary Completion

May 4, 2019

Study Completion

May 4, 2019

Last Updated

June 4, 2019

Record last verified: 2019-05

Locations

US(1)