Circulating Tumor Cell, Circulating Tumor DNA, Non Small Cell Lung Cancer
Conditions
Keywords
early response evaluation, immunotherapy, chemotherapy, liquid biopsy, FDG-PET/CT
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.
Interventions
DEVICEPET/CT
3 extra scans with FDG-PET/CT and 4 blood samples
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy. | 3 months | Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET. |
| Observation of changes in circulating tumor DNA during first treatment. | 3 months | Measure changes in the amount of free circulating DNA |
Countries
Denmark
Contacts
Primary ContactHeidi Ryssel
Backup ContactBarbara Malene Fisher
Outcome results
None listed