Respiration Gated Laser Guided CT Lung Nodule Biopsy

NCT01236937 | Unknown DMC

• 1 other identifier: Gentofte CT guided biopsy
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Cancer

Keywords

CT, lung nodule biopsy, Respiration Gated, Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Accuracy of respiration gated laser guided CT lung nodule biopsy

  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.

  After 2 years

Study Arms (2)

Bellows-based breath hold biopsy

ACTIVE COMPARATOR

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

Device: Bellows-based breath hold device

No Bellows-based breath hold.

NO INTERVENTION

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

Device: Bellows-based breath hold device

Interventions

Bellows-based breath hold device 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.

Bellows-based breath hold biopsy; No Bellows-based breath hold.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Gentofte University Hospital, Department of Radiology

Hellerup, Copenhagen, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Haseem Ashraf, MD, PhD

  Gentofte University Hospital, Department of Radiology

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Central Study Contacts

Haseem Ashraf, MD, PhD

CONTACT

haseem.ashraf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 9, 2010

Record last verified: 2010-05

Locations

DK (1)