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

Rigshospitalet

Status: Unknown

Conditions: Circulating Tumor DNA; Circulating Tumor Cell; Non Small Cell Lung Cancer

Treatments: Device: PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03481101

H-17016437

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

All patients

Other group

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.

Treatment:

Device: PET/CT