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

October 6, 2020 updated by: heidi ryssel, Rigshospitalet, Denmark

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • University of Copenhagen
      • Copenhagen, Denmark, 2200
        • Not yet recruiting
        • University Copenhagen
        • Contact:
          • heidi ryssel
          • Phone Number: +4528727532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Device: PET/CT
3 extra scans with FDG-PET/CT and 4 blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy.
Time Frame: 3 months
Measure changes in standardized uptake value (SUV) in tumorcells by FDG-PET.
3 months
Observation of changes in circulating tumor DNA during first treatment.
Time Frame: 3 months
Measure changes in the amount of free circulating DNA
3 months
Observation of changes in circulating tumor DNA during first treatment.
Time Frame: 3 months
Measure changes in cancer DNA by whole genome sequencing on free circulating DNA.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Andreas Kjær, Klinisk fysiologisk og Nuclearmedicinsk afd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 28, 2018

Primary Completion (ANTICIPATED)

February 26, 2021

Study Completion (ANTICIPATED)

February 28, 2021

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (ACTUAL)

March 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17016437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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