Non Small Cell Lung CancerWHENIINCT03481101
WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC
A study testing PET/CT in people with Non Small Cell Lung Cancer and Circulating Tumor Cell, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer, Circulating Tumor Cell, Circulating Tumor DNA
- What is being tested?
- PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- 28 Feb 2018to 28 Feb 2021
- 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
Who may be able to join
- Patients with non-small cell lung cancer (NSCLC) who is about to start treatment with chemo- or immune therapy. No prior treatment of the one given.
- Measurable decease according to RECIST criteria
- Age > 18 years
- Performance status 0-2 (0-1 for immunotherapy)
- Understands and reads danish
Who cannot join
- Poor performance status
- Secondary active cancer
- Pregnancy
- Dysregulated diabetes mellitus
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Not yet recruiting
University Copenhagen
Copenhagen, 2200
heidi ryssel, +4528727532
- Recruiting
University of Copenhagen
Copenhagen
About this study
Official title: WHENII - Early Response Evaluation With 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose(FDG)- Positrons Emissions Tomography(PET)/CT and Liquid Biopsy in Patients With NSCLC (Non Small Cell Lung Cancer)
Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
Read the detailed description
Interventional study of patients with inoperable lung cancer of non small cell type undergoing 1st treatment of either chemotherapy or immunotherapy. Patients are evaluated with FDG-PET/ct and blood analyses og circulating tumor DNA and cancer markers to determine early response.
PET-CT are preceded before and after treatment is given;
- day 0 before treatment,
- day 2 after treatment and
- day 21 just before second treatment. At every FDG-PET/ct scan blood are examined for circulating tumor DNA (ctDNA) and potentially cancer markers by White genome sequencing. In total 3 PET-CT scans and 4 blood samples are performed. The result are compared with the standard CT scan after 2-3 cycles of treatment. Blood analyses are repeated after 2-3 cycles to observe any changes.
- Being tested
- PET/CT
- Keywords
- early response evaluation, immunotherapy, chemotherapy, liquid biopsy, FDG-PET/CT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
3 extra scans with FDG-PET/CT and 4 blood samples
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Both patients receiving chemotherapy and immunotherapy are observed during the same intervention with PET/CT and liquid biopsy. No primary comparison are made between the groups. Receives: Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy.
Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET.
Measured: 3 months
Observation of changes in circulating tumor DNA during first treatment.
Measure changes in the amount of free circulating DNA
Measured: 3 months
Observation of changes in circulating tumor DNA during first treatment.
Measure changes in cancer DNA by whole genome sequencing on free circulating DNA.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start28 Feb 2018
- Primary completion26 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
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 CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heidi ryssel, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Andreas Kjær, Study director, Klinisk fysiologisk og Nuclearmedicinsk afd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481101
- Sponsor's protocol ID
- H-17016437
- Acronym
- WHENII
- Status last verified
- Oct 2020
- First submitted
- 5 Mar 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHENII - Early Response Evaluation With 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose(FDG)- Positrons Emissions Tomography(PET)/CT and Liquid Biopsy in Patients With NSCLC (Non Small Cell Lung Cancer)
- ClinicalTrials.gov ID
- NCT03481101
- Acronym / sponsor ID
- WHENII / H-17016437
- Keywords
- early response evaluation, immunotherapy, chemotherapy, liquid biopsy, FDG-PET/CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 26 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 29 Mar 2018 (actual)
- 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.
Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
Detailed description
Interventional study of patients with inoperable lung cancer of non small cell type undergoing 1st treatment of either chemotherapy or immunotherapy. Patients are evaluated with FDG-PET/ct and blood analyses og circulating tumor DNA and cancer markers to determine early response.
PET-CT are preceded before and after treatment is given;
- day 0 before treatment,
- day 2 after treatment and
- day 21 just before second treatment. At every FDG-PET/ct scan blood are examined for circulating tumor DNA (ctDNA) and potentially cancer markers by White genome sequencing. In total 3 PET-CT scans and 4 blood samples are performed. The result are compared with the standard CT scan after 2-3 cycles of treatment. Blood analyses are repeated after 2-3 cycles to observe any changes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Device: PET/CTBoth patients receiving chemotherapy and immunotherapy are observed during the same intervention with PET/CT and liquid biopsy. No primary comparison are made between the groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-small cell lung cancer (NSCLC) who is about to start treatment with chemo- or immune therapy. No prior treatment of the one given.
- Measurable decease according to RECIST criteria
- Age > 18 years
- Performance status 0-2 (0-1 for immunotherapy)
- Understands and reads danish
Key exclusion criteria (4 listed)
- Poor performance status
- Secondary active cancer
- Pregnancy
- Dysregulated diabetes mellitus
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/CT3 extra scans with FDG-PET/CT and 4 blood samples | Device | All patients |
Primary outcome
Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy.
Time frame: 3 months
Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET.
Observation of changes in circulating tumor DNA during first treatment.
Time frame: 3 months
Measure changes in the amount of free circulating DNA
Observation of changes in circulating tumor DNA during first treatment.
Time frame: 3 months
Measure changes in cancer DNA by whole genome sequencing on free circulating DNA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Kjær study director
Klinisk fysiologisk og Nuclearmedicinsk afd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT in people with Non Small Cell Lung Cancer and Circulating Tumor Cell, run by Copenhagen University Hospital, Rigshospitalet at 2 sites 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Ryssel (+4528727532, heidi.ryssel@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy. (time frame: 3 months). The study lists 3 primary outcomes in all. 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 8 Oct 2020.