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

This study is currently recruiting participants.
Verified August 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01206894
First received: September 14, 2010
Last updated: September 3, 2013
Last verified: August 2013

September 14, 2010
September 3, 2013
September 2010
December 2013   (final data collection date for primary outcome measure)
The primary outcome will be the accuracy of real-time chest ultrasonographic in assessing chest wall invasion compared to Ultrasound [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Sensitivity, specificity will be calculated for US and CT scan for assessing chest wall invasion.
Same as current
Complete list of historical versions of study NCT01206894 on ClinicalTrials.gov Archive Site
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Pre-Operative Assessment of Chest Wall Invasion in NSCLC Using Pre-Operative, Surgeon Performed Ultrasound
Pre-Operative Assessment of Chest Wall Invasion in Non-Small Cell Lung Cancer (NSCLC)Using Pre-Operative, Surgeon Performed Ultrasound

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

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Non Small Cell Lung Cancer
Procedure: Transthoracic Ultrasound
1 transthoracic ultrasound will be performed the evening before the thoracic surgery
Other Name: Chest wall invasion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
March 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Vicky Thiffault, RN, CCRP 514-890-8000 ext 23432 vicky.thiffault.chum@ssss.gouv.qc.ca
Canada
 
NCT01206894
CE 10.119
No
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Principal Investigator: Moishe Liberman, MD, PhD Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
August 2013

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