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NCT Number: NCT01206894

Pre-Operative Assessment of Chest Wall Invasion in 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transthoracic Ultrasound

Procedure

1 transthoracic ultrasound will be performed the evening before the thoracic surgery

Other names: Chest wall invasion

Primary outcomes

  1. 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

    Sensitivity, specificity will be calculated for US and CT scan for assessing chest wall invasion.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Registry information

Official study title

Pre-Operative Assessment of Chest Wall Invasion in Non-Small Cell Lung Cancer (NSCLC)Using Pre-Operative, Surgeon Performed Ultrasound

Acronym: CT0010

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2010
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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