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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00123747
First received: July 22, 2005
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Lung Neoplasms
Procedure: Positron Emission Tomography (PET) scan Imaging
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: August 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123747

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Alexander McEwan, MB, MSc, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00123747     History of Changes
Other Study ID Numbers: LU-11-0044/DX-FDG-007/21389
Study First Received: July 22, 2005
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Positron Emission Tomography
Fluorodeoxyglucose F18
Tomography scanners, X-Ray Computed

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Deoxyglucose
Fluorodeoxyglucose F18
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014