Houston, Texas 77030


Purpose:

The goal of this clinical research study is to compare the results of EBUS-TBNA with the results of PET/CT scans to learn about the accuracy of these ways to find evidence of early stage lung cancer.


Study summary:

EBUS-TBNA: If participant agrees to take part in this study, as a part of participant's standard-of-care, participant will have an EBUS-TBNA before SBRT. Participant will have this performed as an out-patient procedure while under general anesthetic. Participant will receive a separate consent for this that will explain the procedure and the risks. The samples collected from the EBUS-TBNA will be tested and compared with the results of participant's standard PET/CT scans. Follow-Up: As a part of participant's standard-of-care, after SBRT participant will have a physical exam and chest CT scan to check the status of the disease every 3 months for the first 2 years, and then twice a year for the following year. After 3 years, participant will have these visits 1 time a year. Participant's medical information from these follow-up visits will be collected for this study. All the information for the study will be stored in a password-protected system. Length of Study Participation: Participant's active participation in this study will be over after participant's tissue samples are collected by EBUS-TBNA. Participant's medical information will continue to be collected as long as participant is coming for follow-up visits. This is an investigational study. The EBUS-TBNA is performed using FDA-approved and commercially available methods. It is investigational to compare the results of EBUS-TBNA and PET/CT scans to learn about the accuracy of these ways to find evidence of early stage lung cancer. Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.


Criteria:

Inclusion Criteria: 1. Patient must be > 18 years old Age 18 years or older 2. Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical Stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1or T2a, N0 or N1, M0) 3. Patient must have a PET/CT obtained within 40 days of having the EBUS-TBNA 4. Patient is being considered for SBRT 5. Patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures 6. If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a) Patient has undergone potentially curative therapy for all prior malignancies b) No evidence of active / recurrent disease within 5 years Exclusion Criteria: 1. Patient has received prior chemotherapy or radiotherapy for this cancer 2. Patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression) 3. Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology 4. Patients who are planning to undergo treatment in a different institutionMalignancy consistent with a neuroendocrine histology


NCT ID:

NCT02719847


Primary Contact:

Principal Investigator
George A. Eapen, MD
M.D. Anderson Cancer Center

George A. Eapen, MD
Phone: 713-563-4256
Email: geapen@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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