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Mediastinal LymphadenopathyNCT04200105

EBUS-TBNA vs Acquire TBNB

A study testing EBUS-TBNA and Acquire TBNB in people with Mediastinal Lymphadenopathy, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims to determine whether a new type of needle used for sampling lymph nodes (glands) around the airways of the lung, during a procedure called an endobronchial ultrasound (EBUS, provides more or better quality tissue to allow a definite diagnosis to be made than with the current standard sampling needle. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mediastinal Lymphadenopathy
What is being tested?
EBUS-TBNA and Acquire TBNB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteUnited Kingdom
Study dates
2 Mar 2020to 1 Aug 2021
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

  • Scheduled for EBUS-TBNA as part of clinical care
  • Lymph node size ≥5mm on CT scan
  • Age > 18 years
  • Written informed consent

Who cannot join

  • Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia, other bleeding diathesis)
  • Inability to obtain informed consent

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Royal Brompton Hospital

    London, SW3 6NP

Other trials in United Kingdom

About this study

Official title: Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus the Endobronchial Ultrasound Transbronchial Needle Biopsy Using the Acquire Needle in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial

This study aims to determine whether a new type of needle used for sampling lymph nodes (glands) around the airways of the lung, during a procedure called an endobronchial ultrasound (EBUS, provides more or better quality tissue to allow a definite diagnosis to be made than with the current standard sampling needle. Two hundred and fifty patients will be randomised to procedures using either the new or standard needle, and the results compared.

Read the detailed description

The causes of mediastinal lymphadenopathy include infection, reactive lymphadenopathy, granulomatous disorders, and malignancy (metastases from various primaries, lymphoma, thymoma, neurogenic tumours). Radiological appearances are usually inadequate at providing a definitive diagnosis. In granulomatous disorders such as sarcoidosis as well as certain infections including tuberculosis, there is frequently mediastinal or hilar lymph node involvement without evidence of disease activity in other organs or lymph node groups. In malignancy, the metastatic involvement of lymph nodes has important prognostic significance. However, lymph node enlargement as seen on computerised tomography (CT) scanning is a poor predictor of disease involvement, and positron emission tomography (PET) of the mediastinum has a 10-15% false positive rate. Adequate mediastinal lymph node sampling is therefore essential in order to reach a definitive diagnosis and obtain satisfactory staging information.

Mediastinal nodal sampling has traditionally been performed using invasive surgical techniques which carry significant morbidity and mortality. These procedures (cervical mediastinoscopy, anterior mediastinotomy) require general anaesthesia and a hospital inpatient stay. Some patients with significant comorbidities are therefore not considered for these procedures as they are deemed unfit for anaesthesia. Safer, less invasive, and more cost-effective procedures using endoscopic ultrasonography to guide needle aspiration of mediastinal lymph nodes have been developed. Endobronchial ultrasound (EBUS) used to guide transbronchial needle aspiration (TBNA) of mediastinal masses has, in a matter of a few years, established itself firmly within the diagnostic and staging algorithm for lung cancer, and also in the diagnosis of other causes of mediastinal and hilar lymphadenopathy such as sarcoidosis and tuberculosis. A wide range of studies has demonstrated the effectiveness and safety of this technique, with various studies reporting sensitivities of between 67% and 92%3.

EBUS-guided needle aspirates performed with 22 gauge needles yield cytological specimens which are often inadequate at providing a firm diagnosis, or at confidently excluding other malignancies such as lymphoma. Immunohistochemistry and mutational analysis are today playing a more important role in the treatment of lung cancer. There is an increasing need for larger tissue samples and ideally biopsy material to enable advanced histopathological examination of specimens. For example, a substantial percentage of lung cancers express cell surface epidermal growth factor receptors (EGFRs). Small molecules designed to inhibit the tyrosine kinase (TK) domain of the EGFR, such as gefitinib and erlotinib, have demonstrated biologic and clinical responses in patients with mutations within the EGFR-TK domain. These TK inhibitors are now an important component of the armamentarium of the thoracic oncologist in the treatment of lung cancer. It has therefore become essential to establish the EGFR mutation status of lung cancers before consideration of treatment. Mutations of the KRAS gene in lung cancer patients have been shown to confer resistance to both erlotinib and gefitinib, adding to the importance of testing tissue samples for these mutations as well. In the past, tests for EGFR and KRAS gene mutations could only be performed on block tumours post resection, however advances in molecular biology in recent years have led to the ability to test small biopsy specimens for such mutations by polymerase chain reaction (PCR) analysis, fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). EBUS-TBNA, however, can only provide needle aspirates. These can provide samples adequate for cytological assessment, but do not always contain sufficient material to enable the formation of a cell block, thereby precluding histological assessment. Larger sized core tissue biopsy specimens are therefore likely to help in the histopathological assessment of lung cancer, and also in the diagnosis of sarcoidosis, lymphoma and other causes of mediastinal lymphadenopathy. This is likely to become even more important in the future as new clinically relevant genetic mutations are identified, and appropriate tests developed.

A novel transbronchial needle has been developed. This franseen needle has a crown tipped needle with three symmetrical cutting heels placed in a circumferential pattern designed with the intent to capture more tissue (figure 1). This needle tip was originally designed for use in interventional radiology, and is now the one of the leading designs used in endoscopic ultrasound of the gastrointestinal tract. This new needle can be passed down an EBUS scope and can hypothetically circumvent the deficiencies of EBUS-TBNA highlighted above by providing greater tissue volume for histological assessment and any subsequent molecular and genetic testing.

Being tested
EBUS-TBNA, Acquire TBNB

What participants receive

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

  • EBUS-TBNADevice

    Mediastinal and hilar lymph node sampling using a standard 22G EBUS needle

  • Acquire TBNBDevice

    Mediastinal and hilar lymph node sampling using the Acquire TBNB needle

Study groups in NCT04200105
Study groupRoleWhat they receive
EBUS TBNAActive comparatorPatients will undergo a standard EBUS examination, with sampling using a standard 22G EBUS needle.
Receives: Device: EBUS-TBNA
Acquire TBNBExperimentalPatients will undergo a standard EBUS examination, with sampling using an Acquire TBNB needle.
Receives: Device: Acquire TBNB

What is being measured

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

  1. The difference in cell volume of cancer or other diagnostic tissue obtained between the two study arms

    Measured: 1 week

Secondary outcomes (7)
  1. The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis.

    Measured: 1 month

  2. The difference between the two study arms in the amount of DNA obtained.

    Measured: 1 month

  3. The difference in complication rates between the two study arms.

    Measured: 1 month

  4. The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis.

    Measured: 1 month

  5. The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma.

    Measured: 1 month

  6. The difference in sensitivity for detecting sarcoidosis between the two study arms.

    Measured: 1 month

  7. The difference in sensitivity for detecting lymphoma between the two study arms.

    Measured: 1 month

Timeline

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

  1. First posted16 Dec 2019
  2. Study start2 Mar 2020 (estimated)
  3. Primary completion1 Mar 2021 (estimated)
  4. Study completion1 Aug 2021 (estimated)

Resources

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
Parallel groups
Model description
1:1 randomisation
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200105
Sponsor's protocol ID
274281
Status last verified
Dec 2019
First submitted
12 Dec 2019
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EBUS-TBNA and Acquire TBNB in people with Mediastinal Lymphadenopathy, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.

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 4 inclusion and 2 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 Dec 2019. 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 United Kingdom. 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 Samuel V Kemp, MBBS (02073528121 ext. 88021, s.kemp@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in cell volume of cancer or other diagnostic tissue obtained between the two study arms (time frame: 1 week). 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 Dec 2019.

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