Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Minimum Dose Computed Tomography (MnDCT) scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring ct, scan, lung, follow-up
Eligibility Criteria
Inclusion Criteria: lung cancer patients undergoing resection with intent to cure Exclusion Criteria: age < 18 years
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MnDCT
Arm Description
Outcomes
Primary Outcome Measures
Detection of local recurrent disease
Evaluate the incidence and significance of sub-5mm lung nodules in this patient population
Secondary Outcome Measures
Full Information
NCT ID
NCT00188279
First Posted
September 9, 2005
Last Updated
October 9, 2018
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00188279
Brief Title
Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
Official Title
Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 21, 2005 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to help decide whether a CAT scan performed at a very low dose of radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung cancer in the chest (after surgery).
Detailed Description
Lung Carcinoma is expected to kill 18,900 men and women in Canada in 2004. This is more than the combined total for the next three common cancers. The most important factor that determines patient survival is the stage of disease at presentation. Surgical resection is the best chance of cure. However, patients who undergo lung resection with curative intent have a significant incidence of a second lung cancer at 2% per year and a recurrence rate of 38% at 5 years. The current follow-up of these patients relies on periodic physical examination and chest radiography(CXR). However, CXR is insensitive in the detection of lung nodules when compared to standard Computed Tomography of the thorax (SDCT). Computed Tomography detects smaller lung nodules than CXR however, the radiation dose from a SDCT is roughly equivalent to 20 CXR examinations. Screening studies using Low Dose CT of the Thorax (LDCT) in subjects at high risk for lung cancer have demonstrated that LDCT detects three times as many nodules as CXR and four times as many primary lung cancers at one-third the dose of SDCT. Phantom and clinical work with LDCT performed at UHN/MSH suggests that a further reduction in radiation dose (Minimum Dose CT -MnDCT) is possible for nodule detection. Minimum dose CT is performed at a dose one sixth of a SDCT.In addition, if MnDCT is confirmed to be a more sensitive nodule detection technique, it could be used to
1. Increase the interval between repeat out-patient assessment and thereby 2. Reduce the overall cost of surveillance and inconvenience to the patient and 3. Free up clinic time for the surgeon to review more patients and reduce waiting lists
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
ct, scan, lung, follow-up
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MnDCT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Minimum Dose Computed Tomography (MnDCT) scan
Intervention Description
Minimum Dose Computed Tomography (MnDCT) scan at regular follow up intervals for up to 5 years post-operatively.
Primary Outcome Measure Information:
Title
Detection of local recurrent disease
Time Frame
5 years
Title
Evaluate the incidence and significance of sub-5mm lung nodules in this patient population
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lung cancer patients undergoing resection with intent to cure
Exclusion Criteria:
age < 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narinder Paul, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
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