Lung CancerGENCTBIOPSYNCT01236937
Respiration Gated Laser Guided CT Lung Nodule Biopsy
A study testing Bellows-based breath hold device in people with Lung Cancer, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bellows-based breath hold device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Haseem Ashraf, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Gentofte University Hospital, Department of Radiology
Hellerup, Copenhagen, 2900
Haseem Ashraf, MD, PhD, haseem.ashraf@gmail.com
About this study
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
- Being tested
- Bellows-based breath hold device
- Keywords
- CT, lung nodule biopsy, Respiration Gated, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bellows-based breath hold deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bellows-based breath hold biopsy | Active comparator | CT guided biopsy is preformed with the use a bellows-based breath Receives: 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 Receives: Device: Bellows-based breath hold device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Haseem Ashraf, MD, PhD, Principal investigator, Gentofte University Hospital, Department of RadiologyPaul Clementsen, MD, PhD, Study chair, Gentofte University Hospital, Department of PulmonologyAnnete Nørgaard, MD, PhD, Study chair, Gentofte University Hospital, Department of PulmonologyPeter S. Myschetzky, MD, Study chair, Gentofte University Hospital, Department of RadiologyAsger Dirksen, MD, PhD, Study chair, Gentofte University Hospital, Department of PulmonologyZaigham Saghir, MD, Study chair, Gentofte University Hospital, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236937
- Sponsor's protocol ID
- Gentofte CT guided biopsy
- Acronym
- GENCTBIOPSY
- Status last verified
- May 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiration Gated Laser Guided CT Lung Nodule Biopsy
- ClinicalTrials.gov ID
- NCT01236937
- Acronym / sponsor ID
- GENCTBIOPSY / Gentofte CT guided biopsy
- Conditions
- Lung Cancer
- Keywords
- CT, lung nodule biopsy, Respiration Gated, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bellows-based breath hold biopsy | Active comparator | Device: Bellows-based breath hold deviceCT guided biopsy is preformed with the use a bellows-based breath |
| No Bellows-based breath hold. | No intervention | Device: Bellows-based breath hold deviceCT guided biopsy is preformed without the use a bellows-based breath |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bellows-based breath hold deviceBellows-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. | Device | Bellows-based breath hold biopsy, No Bellows-based breath hold. |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haseem Ashraf, MD, PhD contact
Haseem Ashraf, MD, PhD principal investigator
Gentofte University Hospital, Department of Radiology
Paul Clementsen, MD, PhD study chair
Gentofte University Hospital, Department of Pulmonology
Annete Nørgaard, MD, PhD study chair
Gentofte University Hospital, Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bellows-based breath hold device in people with Lung Cancer, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haseem Ashraf, MD, PhD (haseem.ashraf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of respiration gated laser guided CT lung nodule biopsy (time frame: After 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.