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:
Alberta Health Services
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00123747
First received: July 22, 2005
Last updated: March 15, 2012
Last verified: March 2012
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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 Alberta Health Services:
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
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
Alberta Health Services
Investigators
| Principal Investigator: | Alexander McEwan, MB, MSc, MD | Alberta Health Services |
More Information
Additional Information:
No publications provided
| Responsible Party: | Alberta Health Services |
| 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 Alberta Health Services:
|
Positron Emission Tomography Fluorodeoxyglucose F18 Tomography scanners, X-Ray Computed |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Deoxyglucose Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013