- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481101
WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC (WHENII)
October 6, 2020 updated by: heidi ryssel, Rigshospitalet, Denmark
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heidi Ryssel
- Phone Number: +4528727532
- Email: heidi.ryssel@regionh.dk
Study Contact Backup
- Name: Barbara Malene Fisher
- Phone Number: +45 35459824
- Email: barbara.malene.fischer@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark
- Recruiting
- University of Copenhagen
-
Copenhagen, Denmark, 2200
- Not yet recruiting
- University Copenhagen
-
Contact:
- heidi ryssel
- Phone Number: +4528727532
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Poor performance status
- Secondary active cancer
- Pregnancy
- Dysregulated diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: All patients
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.
|
3 extra scans with FDG-PET/CT and 4 blood samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Observation of changes in circulating tumor DNA during first treatment.
Time Frame: 3 months
|
Measure changes in the amount of free circulating DNA
|
3 months
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Andreas Kjær, Klinisk fysiologisk og Nuclearmedicinsk afd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 28, 2018
Primary Completion (ANTICIPATED)
February 26, 2021
Study Completion (ANTICIPATED)
February 28, 2021
Study Registration Dates
First Submitted
March 5, 2018
First Submitted That Met QC Criteria
March 21, 2018
First Posted (ACTUAL)
March 29, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 6, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-17016437
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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