Back to resultsWHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC (WHENII)
Primary Purpose
Non Small Cell Lung Cancer, Circulating Tumor Cell, Circulating Tumor DNA
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Non Small Cell Lung Cancer focused on measuring early response evaluation, immunotherapy, chemotherapy, liquid biopsy, FDG-PET/CT
Eligibility Criteria
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
Sites / Locations
- University Copenhagen
- University of CopenhagenRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Observation of changes in circulating tumor DNA during first treatment.
Measure changes in the amount of free circulating DNA
Observation of changes in circulating tumor DNA during first treatment.
Measure changes in cancer DNA by whole genome sequencing on free circulating DNA.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03481101
Brief Title
WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC
Acronym
WHENII
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
February 26, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Circulating Tumor Cell, Circulating Tumor DNA
Keywords
early response evaluation, immunotherapy, chemotherapy, liquid biopsy, FDG-PET/CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Description
3 extra scans with FDG-PET/CT and 4 blood samples
Primary Outcome Measure Information:
Title
Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy.
Description
Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET.
Time Frame
3 months
Title
Observation of changes in circulating tumor DNA during first treatment.
Description
Measure changes in the amount of free circulating DNA
Time Frame
3 months
Title
Observation of changes in circulating tumor DNA during first treatment.
Description
Measure changes in cancer DNA by whole genome sequencing on free circulating DNA.
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Ryssel
Phone
+4528727532
Email
heidi.ryssel@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Malene Fisher
Phone
+45 35459824
Email
barbara.malene.fischer@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Kjær
Organizational Affiliation
Klinisk fysiologisk og Nuclearmedicinsk afd
Official's Role
Study Director
Facility Information:
Facility Name
University Copenhagen
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
heidi ryssel
Phone
+4528727532
Facility Name
University of Copenhagen
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC
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