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
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Procedure: Minimum Dose Computed Tomography (MnDCT) scan
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: July 2005
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lung cancer patients undergoing resection with intent to cure

Exclusion Criteria:

  • age < 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188279

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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00188279     History of Changes
Other Study ID Numbers: 05-0051-C
Study First Received: September 9, 2005
Last Updated: September 9, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
ct
scan
lung
follow-up

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

ClinicalTrials.gov processed this record on September 18, 2014