AzTrials
AzTrials

Mediastinal LymphadenopathyNCT01367366

Dx Mediastinal Malignant LAP:Compare PET and EBUS-TBNA

An observational study of Mediastinal Lymphadenopathy, run by National Taiwan University Hospital at 1 site in Taiwan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

Lung cancer is the leading cause of death in Taiwan. The outcomes of the disease vary depending on early detection, histologic types and staging. Because the mediastinal involvement including lymph node status is a significant prognostic factor for survival, lymph node biopsy is necessary for clinical staging of some… 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?
PET and EBUS-TBNA
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteTaiwan
Study dates
May 2010to Apr 2012
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Suspected malignant mediastinal lymphadenopathy

Who may be able to join

  • Age older than 18 years
  • Patient with suspected malignant mediastinal lymphadenopathy

Who cannot join

  • Age younger than 18 years
  • Bleeding diathesis(INR > 1.4, Platelet count < 10,000/mcl)

Trial locations and contacts

1 site in 1 country.

Chao-Chi Ho, PhD contact

886-972651317

ccho1203@gmail.com

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Recruiting

Other trials in Taiwan

About this study

Lung cancer is the leading cause of death in Taiwan. The outcomes of the disease vary depending on early detection, histologic types and staging. Because the mediastinal involvement including lymph node status is a significant prognostic factor for survival, lymph node biopsy is necessary for clinical staging of some patients. Although fluorodeoxyglucose-positron emission tomography (FDG-PET) is suggested for precise evaluation of mediastinum, tissue proof of PET positive lesions are recommended due to its limited diagnostic specificity for identifying mediastinal metastases. Cervical mediastinoscopy remains the "gold standard" for mediastinal lymph node sampling. However, it is invasive, requires general anesthesia. Another new minimally invasive method of mediastinal biopsy is real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The aim of this study is to compare the accuracy of PET and EBUS-TBNA for correct staging of the mediastinum for lung cancer patients.

Read the detailed description

Lung cancer ranks among the most commonly occurring malignancies and currently is the leading cause of cancer-related cause worldwide including Taiwan [1, 2]. Although a lot of research focus on the treatment of lung cancer, the prognosis of lung cancer remains dismal and a five year survival ate is less than 15% [3]. Unfortunately, early detection of lung cancer is still a problem. In a tertiary care hospital in Taiwan, only 27.3% of patients could received operation (stage I 15%, stage II 7.5%) [4]. Lymph node staging is also important for evaluation the possibility of operation.

Fluorodeoxyglucose-positron emission tomography (FDP-PET) is now used by oncologist to evaluate lung masses, solitary pulmonary nodules and intrathoracic lymph nodes. As the technique becomes more widespread, it is now used even as a first line imaging investigation. Although PET has a high negative predictive value, it is neither sensitive nor specific to differentiate benign from malignant mediastinal lymph nodes [5, 6]. If PET positive mediastinal lymph nodes are equal to malignant involvement, some patients might be excluded from potentially curative surgery. Several national guideline groups suggest that PET positive lymph nodes should be biopsied if it is likely that the result will alter clinical management [7, 8].

"Cervical mediastinoscopy" has been regarded as the "standard procedure" for sampling mediastinal lymph nodes. However, these techniques require general anesthesia and could not be repeated because of adhesion. Access to hilar nodal stations can be difficult for mediastinoscopy. In recent years, one minimally invasive method endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used for biopsy of both hilar and mediastinal lymph nodes [9]. EBUS-TBNA allows the mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy, as well as some hilar nodes (lymph node stations 2-4, 7, 10-12)[9] .

Kazuhiro Yasufuku had published the first report of real-time EBUS-TBNA in evaluating mediastinal lymphadenopathy in 2004 [10]. Currently, the main indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and cervical mediastinoscopy [11]. Efficacy in evaluation of other disease processes such as sarcoidosis and lymphoma has also been established [12].

Although there were several large studies to compare the diagnostic efficacy of mediastinal malignant lymphadenopathy between FDG-PET and EBUS-TBNA, the investigators need to have our own data because of high incidence of TB lymphadenitis in Taiwan, where the diagnostic accuracy of PET may be lower than other countries.

Being tested
PET and EBUS-TBNA
Keywords
malignant mediastinal lymphadenopathy, positron emission tomography, endobronchial ultrasound, transbronchial needle aspiration

What participants receive

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

  • PET and EBUS-TBNAProcedure or surgery

    PET and EBUS-TBNA once, respectively

Study groups in NCT01367366
Study groupRoleWhat they receive
Mediastinal malignant lymphadenopathyNot described
Receives: Procedure: PET and EBUS-TBNA

What is being measured

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

  1. Diagnostic value of PET and EBUS-TBNA

    Thg diagnostic criteria for malignant mediastinal lymphadenopathy is as followed:

    1. EBUS-TBNA: postive cytology or patholoy result of the culprit lymph node
    2. PET: SUVmax >2.5 of the culprit lymph node

    The gold standard diagnostic method is surgical biopsy of the culprit lymph node.

    The sensitivity,specificity,positive and negative predictive value will be calculated.

    Measured: 1 week

Timeline

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

  1. First posted7 Jun 2011 (estimated)
  2. Study startMay 2010
  3. Primary completionApr 2012 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01367366
Sponsor's protocol ID
201004018R
Status last verified
May 2011
First submitted
20 May 2010
Last updated
7 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mediastinal Lymphadenopathy, run by National Taiwan University Hospital 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 2 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 7 Jun 2011. 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?

Contact Chao-Chi Ho, PhD (886-972651317, ccho1203@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic value of PET and EBUS-TBNA (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 7 Jun 2011.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in