## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 05-0051-C
#### Organization
**Class:** OTHER
**Full Name:** University Health Network, Toronto
### Status Module
#### Completion Date
**Date:** 2016-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-11

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-10

**Type:** ACTUAL

#### Start Date
**Date:** 2005-06-21

**Status Verified Date:** 2018-10

#### Study First Post Date
**Date:** 2005-09-16
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-09
**Study First Submit QC Date:** 2005-09-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Health Network, Toronto

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Non-small Cell Lung Cancer

**Keywords:**

- ct

- scan

- lung

- follow-up

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 311

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Minimum Dose Computed Tomography (MnDCT) scan

**Label:** MnDCT

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MnDCT

**Description:** Minimum Dose Computed Tomography (MnDCT) scan at regular follow up intervals for up to 5 years post-operatively.

**Name:** Minimum Dose Computed Tomography (MnDCT) scan

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Detection of local recurrent disease

**Time Frame:** 5 years

**Measure:** Evaluate the incidence and significance of sub-5mm lung nodules in this patient population

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* lung cancer patients undergoing resection with intent to cure

Exclusion Criteria:

* age \< 18 years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Toronto

**Country:** Canada

**Facility:** University Health Network

**State:** Ontario

**Zip:** M5G 2C4

#### Overall Officials

**Official 1:**

**Affiliation:** University Health Network, Toronto

**Name:** Narinder Paul, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Carcinoma

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
