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Respiration Gated Laser Guided CT Lung Nodule Biopsy


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Open (Enrolling)
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Lung Cancer

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Trial Information

Respiration Gated Laser Guided CT Lung Nodule Biopsy


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Accuracy of respiration gated laser guided CT lung nodule biopsy

Outcome Description:

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.

Outcome Time Frame:

After 2 years

Safety Issue:

Yes

Principal Investigator

Haseem Ashraf, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gentofte University Hospital, Department of Radiology

Authority:

Denmark: Ethics Committe

Study ID:

Gentofte CT guided biopsy

NCT ID:

NCT01236937

Start Date:

March 2010

Completion Date:

July 2012

Related Keywords:

  • Lung Cancer
  • CT, lung nodule biopsy, Respiration Gated, Lung Cancer
  • Lung Neoplasms

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