Respiration Gated Laser Guided CT Lung Nodule Biopsy (GENCTBIOPSY)

University Hospital, Gentofte, Copenhagen

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: Bellows-based breath hold device

Study type: Interventional

Funder types: Other

Identifiers

NCT01236937

Gentofte CT guided biopsy

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Bellows-based breath hold biopsy

Active Comparator group

Description:

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

Treatment:

Device: Bellows-based breath hold device

No Bellows-based breath hold.

No Intervention group

Description:

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

Treatment:

Device: Bellows-based breath hold device