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

Non Small Cell Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481101
• Other study ID #: H-17016437
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: October 2020
• Source: Rigshospitalet, Denmark
• Contact: Heidi Ryssel
• Phone: +4528727532
• Email: heidi.ryssel[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Circulating Tumor Cell
• Circulating Tumor DNA
• Lung Neoplasms
• Neoplastic Cells, Circulating
• Non Small Cell Lung Cancer

Intervention

Device:
• PET/CT
3 extra scans with FDG-PET/CT and 4 blood samples

Locations

Country	Name	City	State
Denmark	University Copenhagen	Copenhagen
Denmark	University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	Observation of changes in circulating tumor DNA during first treatment.	Measure changes in the amount of free circulating DNA	3 months
Primary	Observation of changes in circulating tumor DNA during first treatment.	Measure changes in cancer DNA by whole genome sequencing on free circulating DNA.	3 months