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Respiration Gated Laser Guided CT Lung Nodule Biopsy

NCT ID: NCT01236937

Last Updated: 2010-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Lung Cancer

Keywords

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CT, lung nodule biopsy, Respiration Gated, Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Bellows-based breath hold biopsy

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

Group Type ACTIVE_COMPARATOR

Bellows-based breath hold device

Intervention Type 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 Bellows-based breath hold.

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

Group Type NO_INTERVENTION

Bellows-based breath hold device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Gentofte University Hospital

Principal Investigators

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Haseem Ashraf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gentofte University Hospital, Department of Radiology

Paul Clementsen, MD, PhD

Role: STUDY_CHAIR

Gentofte University Hospital, Department of Pulmonology

Annete Nørgaard, MD, PhD

Role: STUDY_CHAIR

Gentofte University Hospital, Department of Pulmonology

Peter S. Myschetzky, MD

Role: STUDY_CHAIR

Gentofte University Hospital, Department of Radiology

Asger Dirksen, MD, PhD

Role: STUDY_CHAIR

Gentofte University Hospital, Department of Pulmonology

Zaigham Saghir, MD

Role: STUDY_CHAIR

Gentofte University Hospital, Department of Pulmonology

Locations

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Gentofte University Hospital, Department of Radiology

Hellerup, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Haseem Ashraf, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Haseem Ashraf, MD, PhD

Role: primary

Other Identifiers

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Gentofte CT guided biopsy

Identifier Type: -

Identifier Source: org_study_id