Back to results

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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

We'll reach out to this number within 24 hrs