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Respiration Gated Laser Guided CT Lung Nodule Biopsy (GENCTBIOPSY)

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ClinicalTrials.gov Identifier: NCT01236937
Recruitment Status : Unknown
Verified May 2010 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
First Posted : November 9, 2010
Last Update Posted : November 9, 2010
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen

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).

Condition or disease Intervention/treatment Phase
Lung Cancer Device: Bellows-based breath hold device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Respiration Gated Laser Guided CT Lung Nodule Biopsy
Study Start Date : March 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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.





Primary Outcome Measures :
  1. Accuracy of respiration gated laser guided CT lung nodule biopsy [ Time Frame: After 2 years ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236937


Contacts
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Contact: Haseem Ashraf, MD, PhD haseem.ashraf@gmail.com

Locations
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Denmark
Gentofte University Hospital, Department of Radiology Recruiting
Hellerup, Copenhagen, Denmark, 2900
Contact: Haseem Ashraf, MD, PhD       haseem.ashraf@gmail.com   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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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

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Responsible Party: Haseem Ashraf, Gentofte University Hospital
ClinicalTrials.gov Identifier: NCT01236937     History of Changes
Other Study ID Numbers: Gentofte CT guided biopsy
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: May 2010
Keywords provided by University Hospital, Gentofte, Copenhagen:
CT, lung nodule biopsy, Respiration Gated, Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases