Pulmonary Ventilation/Perfusion Imaging for the Prediction of Postoperative Residual Pulmonary Function

NCT03357094 | Unknown DMC

• 1 other identifier: tr12345
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is one of the most common malignant tumors in the world and with the highest incidence in China. Surgery is the most effective therapeutic method for primary lung cancer. Accurate prediction of residual postoperative pulmonary function in patients, especially those with borderline pulmonary function, is crucial for proper qualification for surgery. According to the 3rd American College of Chest Physicians(ACCP) evidence-based clinical practice guideline (2013), both predictive postoperative (ppo) FEV1.0% and ppoDLCO% are greater than 60% predicted are required as a first standard of lobectomy for patients with primary lung cancer. And, according to the British Thoracic Society (BTS) guideline, patients with ppoFEV1.0% and ppoDLco% less than 40% have high a risk for surgery. Pulmonary ventilation / perfusion SPECT/CT has recently become available for prediction of lung function, and it can be used to forecast pulmonary function in consideration of the pulmonary circulation as well as effective residual lung function. Traditionally, prediction of postoperative lung function was based on planar method in anterior and posterior projections of lung scintigraphy. However, SPECT/CT enables measurement of ventilation / perfusion uptake in each lobe of the lungs in a three dimensional way, which may avoid underestimating ppoFEV1.0% and provide confidence in suggesting lobectomy or pneumonectomy. This experiment is intended to explore the use of Q.lung, a volume-based software to semi-quantitatively calculate pulmonary ventilation/perfusion functional uptake and volume by SPECT/CT. We hope it can get a more accurate prediction of postoperative residual pulmonary function to provide better management for clinical surgery.

Conditions

Lung Neoplasms

Keywords

Pulmonary ventilation; Pulmonary perfusion; Single Photon Emission Computed Tomography

Outcome Measures

Primary Outcomes (3)

• compare actual postoperative lung function values to predicted values using residual pulmonary lobar volume by SPECT/CT

  using pulmonary lobar volume to calculate predicted postoperative pulmonary test values and compare them with actual postoperative values.

  1 month

• compare actual postoperative lung function values to predicted values using residual ventilation uptake by SPECT/CT

  using ventilation uptake (in counts) to calculate predicted postoperative pulmonary test values and compare them with actual postoperative values.

  1 month

• compare actual postoperative lung function values to predicted values using residual perfusion uptake by SPECT/CT

  using perfusion uptake (in counts) to calculate predicted postoperative pulmonary test values and compare them with actual postoperative values.

  1 month

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed and pre-therapeutic patients with primary lung cancer.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• West China Hospital: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Henan Cancer Hospital: collaborator
• Zhejiang Tumor Hospital: collaborator
• RenJi Hospital: collaborator

Study Sites (1)

Tongren Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

wang shuang, master

CONTACT

010-58268056; wangs198801@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: November 29, 2017
• Study Start: September 30, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: November 29, 2017

Record last verified: 2017-10

Locations

CN (1)