Lung CancerNCT03617029
Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection
A study testing Microcoil and Lipiodol in people with Lung Cancer, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages. Surgical resection is still the main treatment for those suspected malignant lesions. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Microcoil and Lipiodol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2019to Dec 2019
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deep lung lesions
Who cannot join
- Emphysema COPD Previous ilpislateral surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Hsin-Chu Branch
Taipei, Hsin-Chu County, 30059
Chiu-kuei Nien, 886-3-5326151, hch01215@hch.gov.tw
About this study
Official title: Preoperative Localization With Microcoil Placement or Contrast Injection for Deep-seated Pulmonary Nodule : A Prospective Randomized Trial
In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages.
Surgical resection is still the main treatment for those suspected malignant lesions. In the face of such small pulmonary nodules, accurate preoperative localization has become the key to successful resection, and the deep-seated nodules are the most challenging parts. Because the deep-seated nodules cannot be localized by surface dye injection, however, it is necessary to place a fiducial marker (such as a microcoil) or contrast medium injection in combination with intraoperative fluoroscopy to ensure adequate resection of the deep-seated nodules. . This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 60 patients with pulmonary nodules with a depth larger than 2 cm will be randomly assigned into two groups. One group will receive microcoil placement, and the other group will receive contrast medium injection. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.
- Conditions
- Lung Cancer
- Being tested
- Microcoil, Lipiodol
- Keywords
- Deep-seated, Needle localization, CT-guided, Thoracoscopy, Fiducial marker
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocoilDevice
Needle localization with microcoil
LipiodolDrug
Needle localization with contrast injection
| Study group | Role | What they receive |
|---|---|---|
| Microcoil | Experimental | Needle localization for deep-seated lung nodules with microcoil placement Receives: Device: Microcoil |
| Contrast | Active comparator | Needle localization for deep-seated lung nodules with contrast injection Receives: Drug: Lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success rate
Procedure success is defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire. The procedure success rate is calculated as follows: procedure success rate (%) = (number of procedure success / number of total procedure) × 100.
Measured: 1 day
Successful localization for surgery
Localization contribute to surgery
Measured: 1 day
Secondary outcomes (4)
Procedure-related complication rate
Incidence of complications during needle procedure, The procedure-related complication rate is calculated as follows: procedure-related complication rate (%) = (number of procedure-related complication / number of total procedure) × 100.
Measured: 1 day
Duration of the localization procedure
From start of needle procedure to withdraw of the needle (minutes)
Measured: 1 day
Duration of wedge resection
From start of surgery to completion of pulmonary wedge resection (minutes)
Measured: 1 day
Surgical margin of wedge resection
Distance from pulmonary lesion to resection margin of the specimen
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study startJan 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617029
- Sponsor's protocol ID
- 107-032-F
- Status last verified
- Nov 2018
- First submitted
- 12 Jul 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Localization With Microcoil Placement or Contrast Injection for Deep-seated Pulmonary Nodule : A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03617029
- Acronym / sponsor ID
- 107-032-F
- Conditions
- Lung Cancer
- Keywords
- Deep-seated, Needle localization, CT-guided, Thoracoscopy, Fiducial marker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 Aug 2018 (actual)
- 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.
In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages.
Surgical resection is still the main treatment for those suspected malignant lesions. In the face of such small pulmonary nodules, accurate preoperative localization has become the key to successful resection, and the deep-seated nodules are the most challenging parts. Because the deep-seated nodules cannot be localized by surface dye injection, however, it is necessary to place a fiducial marker (such as a microcoil) or contrast medium injection in combination with intraoperative fluoroscopy to ensure adequate resection of the deep-seated nodules. . This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 60 patients with pulmonary nodules with a depth larger than 2 cm will be randomly assigned into two groups. One group will receive microcoil placement, and the other group will receive contrast medium injection. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microcoil | Experimental | Device: MicrocoilNeedle localization for deep-seated lung nodules with microcoil placement |
| Contrast | Active comparator | Drug: LipiodolNeedle localization for deep-seated lung nodules with contrast injection |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Deep lung lesions
Key exclusion criteria (1 listed)
- Emphysema COPD Previous ilpislateral surgery
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 |
|---|---|---|
| MicrocoilNeedle localization with microcoil | Device | Microcoil |
| LipiodolNeedle localization with contrast injection | Drug | Contrast |
Primary outcome
Procedure success rate
Time frame: 1 day
Procedure success is defined as marking (lipiodol or hook-wire) the GGO lesion within 1 cm without pleural leakage of lipiodol or dislodgement of the hook-wire. The procedure success rate is calculated as follows: procedure success rate (%) = (number of procedure success / number of total procedure) × 100.
Successful localization for surgery
Time frame: 1 day
Localization contribute to surgery
4 secondary outcomes
Procedure-related complication rate
Time frame: 1 day
Duration of the localization procedure
Time frame: 1 day
Duration of wedge resection
Time frame: 1 day
Surgical margin of wedge resection
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
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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.
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 and Lipiodol in people with Lung Cancer, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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 4 Dec 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success rate (time frame: 1 day). The study lists 2 primary outcomes in all. 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 4 Dec 2018.