WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC
NCT ID: NCT03481101
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-02-28
2021-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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All patients
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.
PET/CT
3 extra scans with FDG-PET/CT and 4 blood samples
Interventions
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PET/CT
3 extra scans with FDG-PET/CT and 4 blood samples
Eligibility Criteria
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Inclusion Criteria
* Measurable decease according to RECIST criteria
* Age \> 18 years
* Performance status 0-2 (0-1 for immunotherapy)
* Understands and reads danish
Exclusion Criteria
* Secondary active cancer
* Pregnancy
* Dysregulated diabetes mellitus
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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heidi ryssel
Doctor
Principal Investigators
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Andreas Kjær
Role: STUDY_DIRECTOR
Klinisk fysiologisk og Nuclearmedicinsk afd
Locations
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University Copenhagen
Copenhagen, , Denmark
University of Copenhagen
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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heidi ryssel
Role: primary
Other Identifiers
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H-17016437
Identifier Type: -
Identifier Source: org_study_id
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