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

Not Applicable

• Conditions: Circulating Tumor Cell; Non Small Cell Lung Cancer; Circulating Tumor DNA
• Interventions: Device: PET/CT

• Registration Number: NCT03481101
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2018-02-28
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	PET/CT	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.

Primary Outcome Measures

Name	Time	Method
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 cancer DNA by whole genome sequencing on free circulating DNA.

Trial Locations

Locations (2)

University Copenhagen; 🇩🇰 Copenhagen, Denmark

University of Copenhagen; 🇩🇰 Copenhagen, Denmark