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Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients Receiving a Treatment Planning Study of 3 Dimensional Conformal Radiation Therapy Guided by Breath Held CT and PET Imaging for Patients With Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00123747
Recruitment Status : Completed
First Posted : July 26, 2005
Last Update Posted : February 25, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
At this time, computed tomography (CT) is the standard tool used at this institution for the staging of non-small cell lung cancer (NSCLC). For most patients, treatment planning for NSCLC is performed with the patient breathing freely during CT scanning. However, recent research has demonstrated that, by holding one's breath briefly, the NSCLC tumor mass can be held motionless. As a result, the tissue to be treated is better pinpointed and the area treated is significantly decreased through breath-hold planning. This allows for a higher dose of radiation to be given to the cancer. PET scanning is a promising newer imaging modality which has shown to be useful in staging NSCLC. This study hypothesizes that breath-held PET scanning and breath held-CT scanning will allow for more stringent radiotherapy plans, minimizing normal tissue toxicity, as well as potentially increasing the dose deliverable to the primary tumor.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Procedure: Positron Emission Tomography (PET) scan Imaging Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II Study of 18F-Fluorodeoxyglucose (FluGlucoScan) in Patients Receiving a Treatment Planning Study of 3 Dimensional Conformal Radiation Therapy Guided by Breath Held CT and PET Imaging for Patients With Non-Small Cell Lung Cancer
Study Start Date : August 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To define the effect of respiratory-gating upon PET based radiotherapeutic treatment planning parameters relative to the free-breathing condition for patients with NSCLC [ Time Frame: One year ]

Secondary Outcome Measures :
  1. To define the relationship between PET based treatment planning volumes and CT based treatment planning volumes within the realm of respiratory-gating for patients with NSCLC [ Time Frame: One Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female
  • Histologically proven, resected lung cancer of the following histologic types:

    • squamous cell carcinoma;
    • adenocarcinoma;
    • undifferentiated large cell carcinoma;
    • non-small cell; and
    • not otherwise specified.
  • Age equal to or greater than 18 years
  • American Joint Committee (AJC) Stage I-III disease (if all detectable tumours can be encompassed by radiation therapy fields, including both the primary tumour and the involved lymph nodes); patients with positive supraclavicular nodes (N3) are not eligible
  • Able and willing to follow instructions and comply with the protocol
  • Provide written informed consent prior to participation in this study
  • Karnofsky Performance Scale score equal to or greater than 70
  • Measurable disease on the CT and PET images
  • Patient must be deemed eligible for the radical combined-modality therapy.

Exclusion Criteria:

  • Nursing or pregnant females
  • MI disease
  • N3 disease (patients with positive supraclavicular nodes are not eligible)
  • Karnofsky performance status less than 70
  • Patients who have undergone complete tumour resection
  • Patients with post-resection intrathoracic tumour recurrence
  • Evidence of small cell history
  • Age less than 18 years
  • Prior or concurrent malignancy except non-melanomatous skin cancer (unless disease free for at least 5 years)
  • Prior radiotherapy to the thorax or neck
  • Prior chemotherapy
  • Patients with myocardial infarction within the preceding 6 months or symptomatic heart disease, including angina; congestive heart failure; and uncontrolled arrythmias
  • Inability to maintain a state of deep inspiratory breath-hold for a minimum length of time

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00123747

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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
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Principal Investigator: Alexander McEwan, MB, MSc, MD AHS Cancer Control Alberta
Additional Information:
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Responsible Party: AHS Cancer Control Alberta Identifier: NCT00123747    
Other Study ID Numbers: LU-11-0044/DX-FDG-007/21389
First Posted: July 26, 2005    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: March 2012
Keywords provided by AHS Cancer Control Alberta:
Positron Emission Tomography
Fluorodeoxyglucose F18
Tomography scanners, X-Ray Computed
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases