Extensive Staging in Lung Cancer

NCT ID: NCT02030444

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-08-31

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.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard diagnostic work-up

All patients will undergo todays' standard work-up (examination for diagnosing and staging) of lung cancer. This will be individualized for each patient according to current guidelines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Extensive diagnostic work-up

All patients will in addition to standard diagnostic work-up undergo PET-MRI and systematic mediastinal and hilar lymph node mapping using EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration of lymph nodes).

Group Type: EXPERIMENTAL

PET-MRI and EBUS-TBNA

Intervention Type: PROCEDURE

Interventions

PET-MRI and EBUS-TBNA

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sveinung Sørhaug, MD PhD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

St.Olavs Hospital, Trondheim University Hospital, Dept of Thoracic Medicine

Trondheim, , Norway

Countries

Norway

Other Identifiers

ExtStaging-2014.1

Identifier Type: -

Identifier Source: org_study_id