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PET CT Re-Planning NSCLC (4DCT-PET)

Primary Purpose

Lung Cancer, Non-Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/CT Scans
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age equal to or more than 18 years old
  • Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher.
  • Chemo-RT patients of any stage of NSCLC
  • Patients with a measurable tumor on CT scan.
  • Patients who are able to lie supine for two consecutive 25 minutes sessions.

Exclusion Criteria:

  • Trimodality patients who will have surgery within 2 months post RT
  • Previous radiotherapy to intended treatment volumes.
  • Patients with recurrent disease
  • Active malignancy other than lung cancer
  • Pregnancy
  • Failure to provide written informed consent

Sites / Locations

    Outcomes

    Primary Outcome Measures

    GTV volumes
    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC.
    GTV volumes
    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
    GTV volumes
    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
    GTV volumes
    he ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
    GTV volumes
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
    GTV Volumes
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
    GTV Volumes
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
    GTV volumes
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans

    Secondary Outcome Measures

    Full Information

    First Posted
    January 11, 2018
    Last Updated
    August 13, 2020
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03403127
    Brief Title
    PET CT Re-Planning NSCLC (4DCT-PET)
    Official Title
    Prospective Study of CT and PET Imaging During a Course of Radical Radiotherapy to Determine the Dosimetric Benefits of Re-Planning in Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 20, 2008 (Actual)
    Primary Completion Date
    March 25, 2013 (Actual)
    Study Completion Date
    April 28, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study will see whether the addition of more frequent planning CTs during the course of radiation, and of Positron Emission Tomography (PET), a diagnostic test similar to CT, prior to and during a course of radiation may provide information that could potentially be used during the treatment to improve the initial radiation plan.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer, Non-Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET/CT Scans
    Intervention Description
    PET Imaging requires the use of an investigational drug, a radioactively-labelled sugar called 18F-Fluorodeoxyglucose (FDG). FDG is glucose labelled with a radioactive fluorine atom. It is given by intravenous injection and is particularly absorbed by cancer cells. The radioactive signal given off by the FDG can then be detected by the PET scanner providing an image of the cancer (or tumour).
    Primary Outcome Measure Information:
    Title
    GTV volumes
    Description
    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC.
    Time Frame
    2 weeks post RT treatment
    Title
    GTV volumes
    Description
    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
    Time Frame
    4 weeks post RT Treatment
    Title
    GTV volumes
    Description
    The ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
    Time Frame
    7 weeks post RT Treatment
    Title
    GTV volumes
    Description
    he ratio of the GTV volumes defined using 4D CT (GTV4DCT) planning scans is a prognostic parameter for NSCLC
    Time Frame
    3 months post RT treatment
    Title
    GTV volumes
    Description
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
    Time Frame
    2 weeks post RT Treatment
    Title
    GTV Volumes
    Description
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
    Time Frame
    4 weeks post RT Treatment
    Title
    GTV Volumes
    Description
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
    Time Frame
    7 weeks post RT Treatment
    Title
    GTV volumes
    Description
    The ratio of the GTV volumes defined using FDG PET (GTVPET) planning scans
    Time Frame
    3 months post RT treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age equal to or more than 18 years old Patients with NSCLC consenting for radiotherapy to the primary tumor and / or mediastinal / hilar lymph nodes. Prescription doses should be 60Gy or higher. Chemo-RT patients of any stage of NSCLC Patients with a measurable tumor on CT scan. Patients who are able to lie supine for two consecutive 25 minutes sessions. Exclusion Criteria: Trimodality patients who will have surgery within 2 months post RT Previous radiotherapy to intended treatment volumes. Patients with recurrent disease Active malignancy other than lung cancer Pregnancy Failure to provide written informed consent

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    PET CT Re-Planning NSCLC (4DCT-PET)

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