Respiration Gated Laser Guided CT Lung Nodule Biopsy

Lung Cancer Clinical Trial

— GENCTBIOPSY  

Official title:

Respiration Gated Laser Guided CT Lung Nodule Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01236937
• Other study ID #: Gentofte CT guided biopsy
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2010
• Last updated: November 8, 2010
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2010
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Haseem Ashraf, MD, PhD
• Email: haseem.ashraf[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committe
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital, Department of Radiology	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes