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Pre-Operative Assessment of Chest Wall Invasion in NSCLC Using Pre-Operative, Surgeon Performed Ultrasound (CT0010)

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transthoracic Ultrasound
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Small Cell Lung Cancer focused on measuring lung cancer, chest wall invasion, transthoracic ultrasound

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with peripheral pulmonary nodules abutting the visceral pleura on pre-operative CT scan of the chest and who are booked for surgery.

Exclusion Criteria:

  • Inability to consent for the study.
  • Patients less than 18 years old.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal

Outcomes

Primary Outcome Measures

The primary outcome will be the accuracy of real-time chest ultrasonographic in assessing chest wall invasion compared to Ultrasound
Sensitivity, specificity will be calculated for US and CT scan for assessing chest wall invasion.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2010
Last Updated
September 25, 2014
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT01206894
Brief Title
Pre-Operative Assessment of Chest Wall Invasion in NSCLC Using Pre-Operative, Surgeon Performed Ultrasound
Acronym
CT0010
Official Title
Pre-Operative Assessment of Chest Wall Invasion in Non-Small Cell Lung Cancer (NSCLC)Using Pre-Operative, Surgeon Performed Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Non-Small Cell Lung Cancer (75% of lung cancer) is associated with involvement of the parietal pleura and or chest wall (soft tissue and/or bone) in 5-8% of patients. Invasion of the chest wall increases the T staging in the Tumor, Node, Mestasis (TNM) classification system of lung cancer to a T3 and is associated with decreased survival and more extensive operative procedures. The reported 5-year survival for patients with T2 tumors is 58% compared to 38% in patients with T3 lesions. The American college of Chest Physician has still not identified the best tool to assess chest wall invasion by lung cancer, CT-Scan being used by physicians for this assessment. In some studies, CT scan has been shown to have a sensitivity ranging from 42 % to 68 % in assessing chest wall invasion, and a specificity ranging from 66 % to 100 %. Trans-thoracic Ultrasound (US) has the capacity of allowing for dynamic real-time imaging of the pulmonary lesion and the chest wall. Therefore, US has the potential to allow for the appreciation of subtle findings related to the movement of the lesion and lung over the chest wall. Hence, US might be an accurate tool to assess chest wall invasion by lung cancer; thus improving pre-operative diagnosis, staging and operative planning of patient with chest wall invasion. However US is not currently utilized in the pre-operative assessment of patients with lung cancer invading the pleura and chest wall, and has not been extensively studied. In some rare studies evaluating the accuracy of US, results have shown a sensitivity ranging from 89% to 100% and a specificity ranging from 95% to 98% for US detecting chest wall invasion by lung cancer. However those studies got criticized. Bandi et al study, got criticized by the fact that the operators in the study were experienced interventional pulmonologists who perform hundreds of thoracic and endoscopic ultrasound per year. Nobuo et al study took place in 1993, since when the device of US has evolved, the investigators can not apply with certainty the findings of this study. Consequently, there is a need to conduct a study to evaluate the accuracy of US to assess chest wall invasion by lung cancer. In this prospective study the investigators will assess the accuracy of US, and then compare it to the accuracy of the CT-Scan

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
lung cancer, chest wall invasion, transthoracic ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transthoracic Ultrasound
Other Intervention Name(s)
Chest wall invasion
Intervention Description
1 transthoracic ultrasound will be performed the evening before the thoracic surgery
Primary Outcome Measure Information:
Title
The primary outcome will be the accuracy of real-time chest ultrasonographic in assessing chest wall invasion compared to Ultrasound
Description
Sensitivity, specificity will be calculated for US and CT scan for assessing chest wall invasion.
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with peripheral pulmonary nodules abutting the visceral pleura on pre-operative CT scan of the chest and who are booked for surgery. Exclusion Criteria: Inability to consent for the study. Patients less than 18 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moishe Liberman, MD, PhD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25038014
Citation
Tahiri M, Khereba M, Thiffault V, Ferraro P, Duranceau A, Martin J, Liberman M. Preoperative assessment of chest wall invasion in non-small cell lung cancer using surgeon-performed ultrasound. Ann Thorac Surg. 2014 Sep;98(3):984-9. doi: 10.1016/j.athoracsur.2014.04.111. Epub 2014 Jul 16.
Results Reference
derived

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Pre-Operative Assessment of Chest Wall Invasion in NSCLC Using Pre-Operative, Surgeon Performed Ultrasound

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