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Specimen Adequacy and Diagnostic Agreement of Fine Needle Aspiration (FNA) VS. Fine Needle Capillary Sampling (FNC) of Endobronchial Ultrasound-Guided Biopsy of Mediastinal Lymph Nodes


N/A
18 Years
N/A
Not Enrolling
Both
Lymphadenopathy

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Trial Information

Specimen Adequacy and Diagnostic Agreement of Fine Needle Aspiration (FNA) VS. Fine Needle Capillary Sampling (FNC) of Endobronchial Ultrasound-Guided Biopsy of Mediastinal Lymph Nodes


Tissue Sample Collection:

If you agree to take part in this study, you will have your already scheduled endobronchial
ultrasound-guided biopsy performed after you have been given a drug to make you sleep. You
will be asked to sign a separate informed consent for the biopsy procedure.

During a standard of care biopsy procedure, there are normally 3-5 tissue sample collections
performed. For the purposes of this study, you will have a total of 4 tissue collections
performed during the biopsy procedure. Two tissue collections (2) using the FNC method, and
2 tissue collections using the FNA method.

If the first 4 tissue sample collections do not provide good enough tissue samples to
perform the diagnosis, additional sample collections may be performed. If more samples are
collected, these samples will not be used for the purposes of this study and will only be
collected for diagnostic purposes.The sampling will be done by the pulmonologist who is
performing your procedure.

The first 4 tissue samples that are collected for the purposes of this study will be
examined to determine the quality of the sample as well as for diagnostic purposes.

Medical Record Information:

Information from your medical record will be collected 1 time for this study. The
information collected will include information about your diagnosis, the number of radiation
treatments you may have had, and additional information about your medical history. The
information will be de-identified and stored in a research database on a password protected
computer that only the study doctor and study staff will have access to.

Length of Study:

You will remain on study for the duration of biopsy procedure. After the biopsy has been
performed, and your medical record information has been collected you will no longer be on
study.

This is an investigational study. The endobronchial ultrasound-guided biopsy of the lymph
nodes is FDA approved. Both methods of tissue collection (FNA and FNC) are FDA approved for
the purposes of this study.

Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. patients 18 years or older

2. Patients in which EBUS is indicated based on the suspicion of either benign or
malignant disease in mediastinal and/or hilar lymph nodes. This will include patients
who are in the hospital.

Exclusion Criteria:

1. patients under 18 years or younger

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Number of times FNA and FNC agree on patient diagnosis (concordance)

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Rodolfo C. Morice, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0051

NCT ID:

NCT00886847

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Lymphadenopathy
  • Lung
  • Lymphadenopathy
  • Enlarged hilar or/and mediastinal lymph adenopathy
  • Benign
  • Malignant
  • Mediastinal lymph nodes
  • Hilar lymph nodes
  • Fine Needle Aspiration
  • FNA
  • Fine Needle Capillary Sampling
  • FNC
  • Endobronchial Ultrasound-Guided Biopsy
  • EBUS
  • Tissue Sample
  • Suction
  • Lymphatic Diseases

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030