Non-small Cell Lung Cancer PatientsNCT02043002
Early Changes in Positron Emissions Tomography (PET/CT) Scan as Predictors of Clinical Outcome in NSCLC Treated With EGFR Tyrosin Kinase Inhibitors (TKI)
A study testing 18F-FDG-PET scan in people with Non-small Cell Lung Cancer Patients, run by University of Aarhus at 1 site in Denmark.
Trial summary
Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is primary seen in patients harboring a mutation in the EGFR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Patients
- What is being tested?
- 18F-FDG-PET scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung Cancer patients with non-small cell histology and stage IV disease
- candidate for erlotinib treatment as first/ second/ third line of treatment
Who cannot join
- pregnancy
- severe dyspnoea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Changes in 18F-fluorodeoxyglucose Positron Emissions Tomography (18F-FDG-PET/CT) Scan as Predictors of Clinical Outcome in NSCLC Treated With EGFR Tyrosin Kinase Inhibitors (TKI)
Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is primary seen in patients harboring a mutation in the EGFR. However, 10-15% of patients does not harbor a mutation but respond as well. Identifying these patients is a problem and methods are lacking.
Studies have shown that an early 18F FDG-PET might can predict response and outcome in these patients, but further studies are needed to confirm these findings.
- Conditions
- Non-small Cell Lung Cancer Patients
- Being tested
- 18F-FDG-PET scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG-PET scanProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG-PET scan | Experimental | An early evaluation 18F-FDG-PET scan after 7-10 days Receives: Procedure: 18F-FDG-PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-FDG-PET evaluation
Standardized Uptake Values (SUV) will be used as measurement of 18F-FDG uptake
Measured: Time to progression and latest april 2015 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer PatientsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043002
- Sponsor's protocol ID
- Thomas
- Status last verified
- Jan 2014
- First submitted
- 17 Jan 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Changes in 18F-fluorodeoxyglucose Positron Emissions Tomography (18F-FDG-PET/CT) Scan as Predictors of Clinical Outcome in NSCLC Treated With EGFR Tyrosin Kinase Inhibitors (TKI)
- ClinicalTrials.gov ID
- NCT02043002
- Acronym / sponsor ID
- Thomas
- Conditions
- Non-small Cell Lung Cancer Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 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.
Erlotinib, an anti-cancer agent targeting the epidermal growth factor receptor (EGFR), is an active treatment of patients with non-small cell lung cancer (NSCLC). Effect of treatment is primary seen in patients harboring a mutation in the EGFR. However, 10-15% of patients does not harbor a mutation but respond as well. Identifying these patients is a problem and methods are lacking.
Studies have shown that an early 18F FDG-PET might can predict response and outcome in these patients, but further studies are needed to confirm these findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG-PET scan | Experimental | Procedure: 18F-FDG-PET scanAn early evaluation 18F-FDG-PET scan after 7-10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lung Cancer patients with non-small cell histology and stage IV disease
- candidate for erlotinib treatment as first/ second/ third line of treatment
Key exclusion criteria (2 listed)
- pregnancy
- severe dyspnoea
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 |
|---|---|---|
| 18F-FDG-PET scan | Procedure or surgery | 18F-FDG-PET scan |
Primary outcome
18F-FDG-PET evaluation
Time frame: Time to progression and latest april 2015 (up to 2 years)
Standardized Uptake Values (SUV) will be used as measurement of 18F-FDG uptake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG-PET scan in people with Non-small Cell Lung Cancer Patients, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
18F-FDG-PET evaluation (time frame: Time to progression and latest april 2015 (up to 2 years)). 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 19 Apr 2017.