Lung NeoplasmsExtStagingNCT02030444
Extensive Staging in Lung Cancer
A study testing PET-MRI and EBUS-TBNA in people with Lung Neoplasms, run by St. Olavs Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- PET-MRI and EBUS-TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2014to Aug 2018
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Patients undergoing examinations on suspicion of lung cancer (both SCLC and NSCLC) at St. Olavs Hospital
- Potentially curable disease at the referral time (Stage I-III, based on the first CT)
- Age ≥ 18 years
- ECOG Performance 0-2
- 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
- No contraindication for study specific procedure - bronchoscopy, CT, MRI and PET.
- No conditions - medical, social, psychological - which could prevent adequate information and follow-up
- No pregnancy or lactating women
- Written informed consent
Trial locations and contacts
1 site in 1 country.
Norway1 site
St.Olavs Hospital, Trondheim University Hospital, Dept of Thoracic Medicine
Trondheim, 7006
About this study
Official title: Randomized Study Comparing Standard Staging of Lung Cancer With Extended Staging Including EBUS-TBNA and PET-MRI
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.
Read the 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
- PET-MRI 2) systematic mediastinal and hilar lymph node mapping using EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration of lymph nodes)
- 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.
- 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
- Being tested
- PET-MRI and EBUS-TBNA
- Keywords
- Neoplasms Staging, Bronchoscopy, Nuclear Medicine, Radiology
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-MRI and EBUS-TBNAProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard diagnostic work-up | No intervention | 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. |
| Extensive diagnostic work-up | Experimental | 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). Receives: Procedure: PET-MRI and EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: Progression free survival in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: due to difficulties with recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Sveinung Sørhaug, MD PhD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030444
- Sponsor's protocol ID
- ExtStaging-2014.1
- Acronym
- ExtStaging
- Status last verified
- Oct 2018
- First submitted
- 6 Jan 2014
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Standard Staging of Lung Cancer With Extended Staging Including EBUS-TBNA and PET-MRI
- ClinicalTrials.gov ID
- NCT02030444
- Acronym / sponsor ID
- ExtStaging / ExtStaging-2014.1
- Conditions
- Lung Neoplasms
- Keywords
- Neoplasms Staging, Bronchoscopy, Nuclear Medicine, Radiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to difficulties with recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Aug 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- PET-MRI 2) systematic mediastinal and hilar lymph node mapping using EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration of lymph nodes)
- 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.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard diagnostic work-up | No intervention | –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. |
| Extensive diagnostic work-up | Experimental | Procedure: PET-MRI and EBUS-TBNAAll 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-MRI and EBUS-TBNA | Procedure or surgery | Extensive diagnostic work-up |
Primary outcome
Progression free survival
Time frame: Progression free survival in one year
Results and safety
The study was stopped early (reason given: due to difficulties with recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sveinung Sørhaug, MD PhD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-MRI and EBUS-TBNA in people with Lung Neoplasms, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2018. 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 Norway. 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?
The study was stopped early (reason given: due to difficulties with recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Progression free survival in one year). 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 5 Oct 2018.