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

NCT00123747 | Completed Phase 2

• 1 other identifier: LU-11-0044/DX-FDG-007/21389
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Keywords

Positron Emission Tomography; Fluorodeoxyglucose F18; Tomography scanners, X-Ray Computed

Outcome Measures

Primary Outcomes (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

  One year

Secondary Outcomes (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

  One Year

Interventions

Positron Emission Tomography (PET) scan Imaging PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alexander McEwan, MB, MSc, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2005
• First Posted: July 26, 2005
• Study Start: August 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 25, 2016

Record last verified: 2012-03

Locations

CA (1)