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Pulmonary Nodules, SolitaryNAVIGATORNCT05383105

Virtual Bronchoscopic Navigation to Increase Diagnostic Yield in Patients With Pulmonary Nodules

An observational study of Pulmonary Nodules, Solitary, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Nodules, Solitary
What is being tested?
Virtual bronchoscopic navigation
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteNetherlands
Study dates
1 Feb 2021to 1 May 2026
How long will I take part?
1 Day
Phase
Observational
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
  • Adult, Older adult

Study population: Patients undergoing a Virtual bronchoscopy navigation procedure to assess a solitary pulmonary nodule.

Who may be able to join

  • age >18
  • pulmonary nodule(s) suspicious for malignancy or metastases of a known primary tumour
  • a distinct nodule with a diameter of >6 mm in its largest dimension
  • nodule located in the parenchymal tissue >1 cm from the pleura and bronchoscopically accessible through a point of entry
  • willing to give informed consent to the procedure.

Who cannot join

  • any contraindication to undergo bronchoscopy
  • contraindication for general anaesthesia
  • inability to stop anticoagulants or antiplatelets agents according to the UMCG protocol
  • childbearing or breastfeeding women
  • moderate to seyere pulmonary fibrosis
  • severe emphysema with bullae > 5 cm m the vicinity of the target nodule or tunnel.

Trial locations and contacts

1 site in 1 country.

Dirk-Jan Slebos, MD PhD contact

+31503612357

d.j.slebos@umcg.nl

Birgitta Hiddinga, MD contact

+31503612357

b.i.hiddinga@umcg.nl

Netherlands1 site, 1 recruiting
  • UMCG Groningen

    Groningen, 9700 RB

    Birgitta Hiddinga, MD, +31503612357, b.i.hiddinga@umcg.nl

    Recruiting

Other trials in Netherlands

About this study

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs.

The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached.

Read more

Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure.

Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.

Read the detailed description

Background Transthoracic computed tomography (CT)-guided procedures are the current gold Standard for obtaining diagnostic biopsies of solitary pulmonary nodules (SPN) in the peripheral lung. Despite its accuracy and diagnostic yield, this technique is associated with an increased risk of complications, Pneumothorax and severe bleeding are the most frequent complications occurring in up to 27% of cases each.

Novel endobronchial techniques, such as electromagnetic navigation bronchoscopy (ENB) or Virtual bronchoscopic navigation (VBN) are considered safer to approach SPNs. The overall rate of pneumothorax after ENB is 4.3%, and bleeding occurs in only 2.8% of cases. The combination of techniques led to an overall increase of the diagnostic yield.

The newest technique combines VBN with calculating the access to a SPN via a transparenchymal route. In contrast to the gold Standard transthoracic approach, also small lesions, and lesions which cannot be reached transthoracicaliy, located in the innertwo thirdsof the lung can be approached. Detailed clinical data, like the correlation of the diagnostic yield to the specific location of the pulmonary nodule, however, is lacking. In view of the expected lung cancer screening program leading to increasing numbers of especially small pulmonary nodules, this data, however, is considered useful to help to select patients forthe right diagnostic procedure.

Main research question To assess diagnostic yield of the novel Standard of care 'Virtual bronchoscopy navigation" procedure.

Design (including population, confounders/outcomes) A single centre, prospective, observational study of patients undergoing the novel Standard of care Virtual bronchoscopy navigation procedure to assess a pulmonary nodule. Clinical data of at least 100 consecutive patients will be collected.

Expected results With the VBN procedure a histologie diagnosis of a SPN can be obtained safely with high diagnostic yield. Correlation to detailed clinical data is expected to help selecting patients for this procedure in the future.

In the future add on technique such as confocal laser endomicroscopy and fluorescence molecular endoscopy might further improve identification of the lesion during the procedure. Ultimately, we expect that development of this technique will pave the way to a one-stop-shop approach with rapid on-site evaluation followed by local treatment (e.g. microwave ablation) of the malignant pulmonary nodule.

Being tested
Virtual bronchoscopic navigation
Medical subject headings
Solitary Pulmonary Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual bronchoscopic navigationProcedure or surgery

    Also called Archimedes

    Virtual bronchoscopy navigation (VBN) calculates the access to a solitary pulmonary nodule via a trans-parenchymal route. In contrast to the gold Standard transthoracic approach, with this technique also very small lesions (7 mm diameter), and lesions which cannot be reached via the transthoracic route - located in the inner two thirds of the lung - can be approached.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful diagnostic procedure

    Number of procedures with success to access the solitary pulmonary nodule

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start1 Feb 2021
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05383105
Sponsor's protocol ID
202100352
Acronym
NAVIGATOR
Status last verified
Mar 2024
First submitted
16 May 2022
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Nodules, Solitary, run by University Medical Center Groningen at 1 site in Netherlands.

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 5 inclusion and 6 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 18 Mar 2024. 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 Netherlands. 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 Dirk-Jan Slebos, MD PhD (+31503612357, d.j.slebos@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful diagnostic procedure (time frame: During procedure). 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 18 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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