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The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET/CT scan
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or above
  • Histologically or cytologically verified NSCLC
  • Disease stage I (T1-2 N0 M0)
  • Referred from the multi-disciplinary lung cancer conference at Aarhus University Hospital for operation at Skejby Hospital, Aarhus University Hospital
  • Oral and written informed consent

Exclusion Criteria:

  • Medically treated diabetes mellitus
  • Fasting blood-glucoses above 6,7 mM
  • Blood-creatinin above normal
  • Allergies to intravenous contrast
  • Detention according to the Danish laws on psychiatrics that does not comply with participation in a clinical trial
  • Employment at the Dept. of Oncology, Aarhus University Hospital
  • Pregnancy
  • Lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    PET/CT defined target

    Arm Description

    Target defined by use of fluoro-deoxy-glucose (FDG)-PET/CT scan for planning af stereotactic radiotherapy.

    Outcomes

    Primary Outcome Measures

    Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens

    Secondary Outcome Measures

    Intra- and inter-individual variability of target definition

    Full Information

    First Posted
    September 25, 2006
    Last Updated
    May 4, 2021
    Sponsor
    University of Aarhus
    Collaborators
    The Danish Medical Research Council
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00380666
    Brief Title
    The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Technical problems.
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Aarhus
    Collaborators
    The Danish Medical Research Council

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when SBRT is planned for stage I NSCLC.
    Detailed Description
    The trial aims to evaluate the utility of 18FDG-PET/CT in SBRT planning for NSCLC with particular emphasis on the definition of macroscopic and microscopic boundaries of malignant growth. Studies indicate that the definition of the gross tumor volume may gain in quality when CT and 18FDG-PET are combined. In about 30-60% of NSCLC patients considered for radiotherapy, alteration of CT-based treatment volumes is the consequence of a supplementary 18FDG-PET scan. Studies examining the effect of combined PET/CT scans on the delineation of the GTV generally show reduced intra- and inter-clinician variability. Whether this higher degree of consistency is an actual improvement remains to be proven. Pathological specimens from operated NSCLC patients may serve as a gold standard in this respect. To meet the need for tight margins, the clinical target volume in SBRT planning is generally presumed to correspond to the GTV. Whether this clinical practice rests on firm ground is also an issue that can be addressed in a PET-CT-pathology correlation study.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    PET/CT defined target
    Arm Type
    Other
    Arm Description
    Target defined by use of fluoro-deoxy-glucose (FDG)-PET/CT scan for planning af stereotactic radiotherapy.
    Intervention Type
    Procedure
    Intervention Name(s)
    PET/CT scan
    Primary Outcome Measure Information:
    Title
    Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Intra- and inter-individual variability of target definition
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or above Histologically or cytologically verified NSCLC Disease stage I (T1-2 N0 M0) Referred from the multi-disciplinary lung cancer conference at Aarhus University Hospital for operation at Skejby Hospital, Aarhus University Hospital Oral and written informed consent Exclusion Criteria: Medically treated diabetes mellitus Fasting blood-glucoses above 6,7 mM Blood-creatinin above normal Allergies to intravenous contrast Detention according to the Danish laws on psychiatrics that does not comply with participation in a clinical trial Employment at the Dept. of Oncology, Aarhus University Hospital Pregnancy Lactation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Morten Hoyer, MD, PhD
    Organizational Affiliation
    Aarhus University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer

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