Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma

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: NCT00188279
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
University Health Network, Toronto

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).

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Procedure: Minimum Dose Computed Tomography (MnDCT) scan Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
Study Start Date : July 2005
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: MnDCT Procedure: Minimum Dose Computed Tomography (MnDCT) scan
Minimum Dose Computed Tomography (MnDCT) scan at regular follow up intervals for up to 5 years post-operatively.

Primary Outcome Measures :
  1. Detection of local recurrent disease [ Time Frame: 5 years ]
  2. Evaluate the incidence and significance of sub-5mm lung nodules in this patient population [ Time Frame: 5 years ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • lung cancer patients undergoing resection with intent to cure

Exclusion Criteria:

  • age < 18 years

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): NCT00188279

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Narinder Paul, MD University Health Network, Toronto

Responsible Party: University Health Network, Toronto Identifier: NCT00188279     History of Changes
Other Study ID Numbers: 05-0051-C
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by University Health Network, Toronto:

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases