Respiration Gated Laser Guided CT Lung Nodule Biopsy (GENCTBIOPSY)

The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system. Secondary outcome is the rate of complications using laser guided CT biopsy in general and with bellows-based breath hold monitoring system. The study has approval from the The Danish National Committee on Biomedical Research Ethics (ref no: H-4-2010-fsp 1).

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Bellows-based breath hold device

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Hellerup, Copenhagen, Denmark, 2900
      • Recruiting
      • Gentofte University Hospital, Department of Radiology
      • Contact: Haseem Ashraf, MD, PhD; Email: haseem.ashraf@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients with indeterminate lung nodules referred from the department of pulmonary medicine at Gentofte Hospital, Denmark for a CT guided biopsy are considered for inclusion in this study. The biopsy was preformed as part of regular clinical work up of the patient at the department of Radiology Gentofte Hospital, Denmark. Both men and women were included and no age restrictions were applied.

Exclusion Criteria:

Excluded from biopsy were those with poor pulmonary function test with a forced expired volume in the first second (FEV1) < 0.5 L, INR>1.2, blood cloth level under 200* and ECG with sign of ischemic heart disease. The trial is planned to begin 1.March 2010 and run for 2 years ending at 29 February 2012. During this time approx. 400 participants planned for biopsy are accepted to be included in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bellows-based breath hold biopsy; CT guided biopsy is preformed with the use a bellows-based breath	Device: Bellows-based breath hold device; Bellows-Based breath hold monitoring system: The bellows-based breath hold system (IBC, Mayo Clinic Medical Devices, USA) contains of 2 elements; one belt which is strapped around the thorax of the patient and a voltage controlled light unit with 8 lights. Belt stretch from respiratory motion is converted into voltage readings and displayed on the light unit giving biofeedback as different lights are activated depending on the dept of the respiration. Patients are instructed to keep respiration constant at a certain dept during the second the guide needle is inserted by controlling their breath with the help of the light unit. The patient is given a brief introduction to the system as to how the lights get turned on and off due to respiration motion before the biopsy is preformed.
No Intervention: No Bellows-based breath hold.; CT guided biopsy is preformed without the use a bellows-based breath	Device: Bellows-based breath hold device; Bellows-Based breath hold monitoring system: The bellows-based breath hold system (IBC, Mayo Clinic Medical Devices, USA) contains of 2 elements; one belt which is strapped around the thorax of the patient and a voltage controlled light unit with 8 lights. Belt stretch from respiratory motion is converted into voltage readings and displayed on the light unit giving biofeedback as different lights are activated depending on the dept of the respiration. Patients are instructed to keep respiration constant at a certain dept during the second the guide needle is inserted by controlling their breath with the help of the light unit. The patient is given a brief introduction to the system as to how the lights get turned on and off due to respiration motion before the biopsy is preformed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of respiration gated laser guided CT lung nodule biopsy	The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system.	After 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Haseem Ashraf, MD, PhD, Gentofte University Hospital, Department of Radiology; Study Chair: Paul Clementsen, MD, PhD, Gentofte University Hospital, Department of Pulmonology; Study Chair: Annete Nørgaard, MD, PhD, Gentofte University Hospital, Department of Pulmonology; Study Chair: Peter S. Myschetzky, MD, Gentofte University Hospital, Department of Radiology; Study Chair: Asger Dirksen, MD, PhD, Gentofte University Hospital, Department of Pulmonology; Study Chair: Zaigham Saghir, MD, Gentofte University Hospital, Department of Pulmonology

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 9, 2010

Study Record Updates

• Last Update Posted (Estimate): November 9, 2010
• Last Update Submitted That Met QC Criteria: November 8, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: CT, lung nodule biopsy, Respiration Gated, Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Gentofte CT guided biopsy