Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188279
First received: September 9, 2005
Last updated: September 9, 2014
Last verified: September 2014

September 9, 2005
September 9, 2014
July 2005
January 2017   (final data collection date for primary outcome measure)
  • Detection of local recurrent disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Evaluate the incidence and significance of sub-5mm lung nodules in this patient population [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • - Detection of local recurrent disease
  • - Evaluate the incidence and significance of sub-5mm lung nodules in this patient population
  • - The detection of a second primary lung cancer (SPLC)
Complete list of historical versions of study NCT00188279 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma

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).

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

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Non-small Cell Lung Cancer
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.
Experimental: MnDCT
Intervention: Procedure: Minimum Dose Computed Tomography (MnDCT) scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
April 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • lung cancer patients undergoing resection with intent to cure

Exclusion Criteria:

  • age < 18 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00188279
05-0051-C
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Narinder Paul, MD University Health Network, Toronto
University Health Network, Toronto
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP