Lung CancerNCT00323089
Removal of Lung Nodules After Being Marked With a Microcoil
A study testing microcoil insertion and excision in people with Lung Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- microcoil insertion and excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2003to 30 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subcentimetre lung nodule
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracoscopic Resection of Subcentimetre Lung Nodules After Localization Using Percutaneous Inserted Platinum Microcoil Under CT Guidance: a Pilot Study
The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
The addition of real-time CT imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.
Read the detailed description
Lung cancer is the most common cause of cancer death for both men and women in the industrialized world. Small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. The remaining 75% of lung cancers are collectively termed non-small cell lung cancers. When presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. More than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 Overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. Prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. Individuals with peripheral lesions less than 3 cm in diameter (T1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 Patients with small subcentimeter pulmonary nodes may have even better survival with resection. Computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 However, Suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. Forty percent of those nodules were found to be malignant.4 The most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. Furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.
- Conditions
- Lung Cancer
- Being tested
- microcoil insertion and excision
- Keywords
- microcoil, subcentimetre nodules
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microcoil insertion and excisionProcedure or surgery
The objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Arm | Experimental | Preoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN) Receives: Procedure: microcoil insertion and excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary nodule excision with microcoil
Thoracotomy and excision rates
Measured: 6 years
Secondary outcomes (1)
Recurrence and death from lung cancer
Death or CT recurrence of lung cancer
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startApr 2003
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Preoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN)
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Finley, University of British Columbia
- Investigators
- Richard Finley, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323089
- Sponsor's protocol ID
- H02-70562
- Other IDs
- 04-0048, 20R42080
- Status last verified
- Jan 2018
- First submitted
- 8 May 2006
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracoscopic Resection of Subcentimetre Lung Nodules After Localization Using Percutaneous Inserted Platinum Microcoil Under CT Guidance: a Pilot Study
- ClinicalTrials.gov ID
- NCT00323089
- Acronym / sponsor ID
- H02-70562
- Conditions
- Lung Cancer
- Keywords
- microcoil, subcentimetre nodules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 9 May 2006 (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 objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device.
The addition of real-time CT imaging and insertion of platinum microcoil markers to the technique of video assisted thoracoscopic stapled resection of subcentimetre pulmonary nodules, will decrease the rate of open thoracotomies required to completely resect the nodules.
Detailed description
Lung cancer is the most common cause of cancer death for both men and women in the industrialized world. Small cell lung cancer accounts for about 25% of lung cancers and is usually widespread when it first presents. The remaining 75% of lung cancers are collectively termed non-small cell lung cancers. When presentation is by symptoms or incidental discovery, about 50 to 60% of non-small cell lung cancers are parenchymal nodules or masses and 40 to 50% are bronchial or hilar. More than 50% of patients with non-small cell cancer will have distant metastases at the time of diagnosis and only 25% will be potentially resectable for cure.1 Overall survival at five years for lung cancer is approximately 15% and has not significantly improved over the last several decades. Prognosis for lung cancer is affected by many factors but one of the most important is the stage of the disease at presentation. Individuals with peripheral lesions less than 3 cm in diameter (T1) at presentation are ideal candidates for surgical resection and have the best outcomes, with 5-year survival rates as high as 60 to 80%.2 Patients with small subcentimeter pulmonary nodes may have even better survival with resection. Computed tomography can now detect cancers less than 4 mm in diameter, and it has been shown that resection of subcentimetre lung cancers results in a survival rate of up to 85%.3 However, Suzuki et al found 54% of 92 patients undergoing video assisted thoracoscopic excision of subcentimetre nodules, required conversion to a thoracotomy. Forty percent of those nodules were found to be malignant.4 The most common reason for this conversion was failure to localize the nodule using thoracoscopic visualization or palpation. Furthermore, univariate and multivariate analysis of eleven variables revealed that if the distance from the pleural surface was greater than 5 mm, the probability of failure to detect the nodule was 63%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Preoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN)
| Arm | Type | Receives |
|---|---|---|
| Surgical Arm | Experimental | Procedure: microcoil insertion and excisionPreoperative CT-Guided Microcoil Localization (CTML) and Fluoroscopic-Guided Video-Assisted Thoracoscopic (VATS) Wedge Resection of Small Peripheral Pulmonary Nodules (SPPN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subcentimetre lung nodule
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| microcoil insertion and excisionThe objective of this study is to determine if subcentimetre pulmonary nodules can be accurately and safely excised by endoscopic stapling devices after they have been localized using CT and marked with a microcoil device. | Procedure or surgery | Surgical Arm |
Primary outcome
pulmonary nodule excision with microcoil
Time frame: 6 years
Thoracotomy and excision rates
1 secondary outcome
Recurrence and death from lung cancer
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Richard Finley, MD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microcoil insertion and excision in people with Lung Cancer, run by University of British Columbia at 1 site in Canada.
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 0 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: finished, as of the sponsor's last update on 25 Jan 2018. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary nodule excision with microcoil (time frame: 6 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 25 Jan 2018.