NCT03481101

WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer
• Circulating Tumor Cell
• Circulating Tumor DNA

Interventions

Type	Name	Description
DEVICE	PET/CT	3 extra scans with FDG-PET/CT and 4 blood samples

Timeline

• Start date: 2018-02-28
• Primary completion: 2021-02-26
• Completion: 2021-02-28
• First posted: 2018-03-29
• Last updated: 2020-10-08

Locations

2 sites across 1 country: Denmark