Clinical trial NCT02030444: Extensive Staging in Lung Cancer
Official title: Randomized Study Comparing Standard Staging of Lung Cancer With Extended Staging Including EBUS-TBNA and PET-MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Neoplasms
Keywords: Neoplasms Staging
Bronchoscopy
Nuclear Medicine
Radiology
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2014-01-08
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The overall aim of this study is to compare standard staging of lung cancer (which includes clinical examination, CT, MRI, bone scan and PET-CT) with comprehensive staging - which includes the new staging methods (PET-MRI and systematic mapping of mediastinal and hilar lymph nodes using endobronchial ultrasound) with respect to disease stage and outcomes of therapy.

Detailed description: The trial is a randomized, explorative study. Patients undergoing examinations for suspicions of lung cancer (Stage I-III) are randomized to either standard diagnostic work-up for lung cancer (Arm A, n=75) or comprehensive diagnostic work-up (Arm B, n=75) with standard examinations plus endobronchial-screening for metastatic lymph nodes (EBUS-TBNA) and PET-MRI.

All patients will undergo todays' standard examination for diagnosing and staging lung cancer. This will be individualized for each patient according to current guidelines. In addition to the standard diagnostic work-up, patients in the interventional group (ArmB) will undergo

1) PET-MRI 2) systematic mediastinal and hilar lymph node mapping using EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration of lymph nodes)

1. PET-MRI PET-MRI will be done immediate after the standard PET-CT using the same infusion of tracer (18-fluorodeoxyglucose, FDG). The sequence protocols used for MRI will be standardized for the study, according to each body compartment. Measurement of Standard Uptake Values (SUV) of the tracer (FDG) will be recorded in pathological lesions. In the mediastinum, each lymph node station will be evaluated with description of visible nodes.
2. Systematic mediastinal mapping The EBUS-TBNA will be done at the initial bronchoscopy and using standard conscious sedation according to the local guidelines at St.Olavs Hospital. Each lymph node station (station 2, 4, 7, 10 and 11 bilateral) will be examined and all lymph nodes ≥ 0,5 cm in short diameter that is easily accessible will be punctured for rapid on-site cytological evaluation (ROSE).

After the initial diagnostic work-up is completed, the patient will be given treatment according to existing guidelines for lung cancer based on the given clinical stage.

For patients undergoing surgery all accessible lymph nodes will be resected according to standard practice. Every resected lymph node will be carefully named according to the standard lymph station for comparison with clinical findings.

Eligibility criteria: 1. Patients undergoing examinations on suspicion of lung cancer (both SCLC and NSCLC) at St. Olavs Hospital
2. Potentially curable disease at the referral time (Stage I-III, based on the first CT)
3. Age ≥ 18 years
4. ECOG Performance 0-2
5. No serious concomitant disorders (for example marked reduced respiratory capacity, active infection, unstable cardiovascular disease, renal dysfunction) that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study procedure
6. No contraindication for study specific procedure - bronchoscopy, CT, MRI and PET.
7. No conditions - medical, social, psychological - which could prevent adequate information and follow-up
8. No pregnancy or lactating women
9. Written informed consent

Primary outcomes:
measure: Progression free survival
timeFrame: Progression free survival in one year
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs Hospital, Trondheim University Hospital, Dept of Thoracic Medicine
Study officials:
affiliation: St. Olavs Hospital
name: Sveinung Sørhaug, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: