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Respiration Gated Laser Guided CT Lung Nodule Biopsy (GENCTBIOPSY)

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Bellows-based breath hold device

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring CT, lung nodule biopsy, Respiration Gated, Lung Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Gentofte University Hospital, Department of RadiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Bellows-based breath hold biopsy

No Bellows-based breath hold.

Arm Description

CT guided biopsy is preformed with the use a bellows-based breath

CT guided biopsy is preformed without the use a bellows-based breath

Outcomes

Primary Outcome Measures

Accuracy of respiration gated laser guided CT lung nodule biopsy

Secondary Outcome Measures

Full Information

NCT ID

NCT01236937

First Posted

November 8, 2010

Last Updated

November 8, 2010

Sponsor

University Hospital, Gentofte, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT01236937

Brief Title

Respiration Gated Laser Guided CT Lung Nodule Biopsy

Acronym

GENCTBIOPSY

Official Title

Respiration Gated Laser Guided CT Lung Nodule Biopsy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

CT, lung nodule biopsy, Respiration Gated, Lung Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bellows-based breath hold biopsy

Arm Type

Active Comparator

Arm Description

CT guided biopsy is preformed with the use a bellows-based breath

Arm Title

No Bellows-based breath hold.

Arm Type

No Intervention

Arm Description

CT guided biopsy is preformed without the use a bellows-based breath

Intervention Type

Device

Intervention Name(s)

Bellows-based breath hold device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Accuracy of respiration gated laser guided CT lung nodule biopsy

Description

Time Frame

After 2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haseem Ashraf, MD, PhD

haseem.ashraf@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haseem Ashraf, MD, PhD

Organizational Affiliation

Gentofte University Hospital, Department of Radiology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paul Clementsen, MD, PhD

Organizational Affiliation

Gentofte University Hospital, Department of Pulmonology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Annete Nørgaard, MD, PhD

Organizational Affiliation

Gentofte University Hospital, Department of Pulmonology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Peter S. Myschetzky, MD

Organizational Affiliation

Gentofte University Hospital, Department of Radiology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Asger Dirksen, MD, PhD

Organizational Affiliation

Gentofte University Hospital, Department of Pulmonology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Zaigham Saghir, MD

Organizational Affiliation

Gentofte University Hospital, Department of Pulmonology

Official's Role

Study Chair

Facility Information:

Facility Name

Gentofte University Hospital, Department of Radiology

City

Hellerup

State/Province

Copenhagen

ZIP/Postal Code

2900

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haseem Ashraf, MD, PhD

haseem.ashraf@gmail.com

12. IPD Sharing Statement

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Respiration Gated Laser Guided CT Lung Nodule Biopsy

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