Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Infections

Wounds and Injuries

Symptoms and General Pathology

Lung Neoplasms

Pneumonia

Radiation Pneumonitis

Communicable Diseases

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Lung Diseases, Interstitial

Lung Injury

Radiation Injuries

Patients will have pre-treatment and post-treatment perfusion DECT for baseline and post-treatment lung function

Thoracic radiotherapy

This is a prospective observational study aiming: 1) To quantify lung function using perfusion dual energy computed tomography (DECT) and use this information at the time of treatment planning with preferential sparing of functional lung parenchymal 2) to validate results of lung function obtained using DECT with lung perfusion scintigraphy results, the current standard method; 4) to compare dosimetry of whole lungs vs. functional lungs in patients treated with either stereotactic body radiotherapy (SBRT) for early stage lung cancer or conventional radiotherapy for locally advanced lung cancer and 5) to evaluate lung function 6, 12 and 24 months post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.

Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.

PHASE I-II Study on the Use of Dual Energy Computed Tomography for Assessment of Lung Function in Thoracic Conventional and Stereotactic Body Radiotherapy

To quantify lung function using perfusion DECT and use this information at the time of treatment planning with preferential sparing of functional lung parenchyma.

To evaluate lung function post-radiotherapy with both perfusion DECT and pulmonary function tests and compare radiation dose-map to functional lung-map.

Varian Medical Systems

Centre hospitalier de l'Université de Montréal (CHUM)

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Platelet Aggregation Inhibitors

Fentanyl

Anesthetics

Rocuronium

Propofol

Sevoflurane

Lung cancer patients undergoing thoracoscopic lobectomy without tracheal intubation

Lung cancer patients undergoing thoracoscopic lobectomy with tracheal intubation and one-lung ventilation

Nonintubated general anesthesia using fentanyl, target-controlled infusion of propofol to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a spontaneous breathing due to iatrogenic pneumothorax.

Nonintubated thoracoscopic lobectomy

Intubated general anesthesia using 2%-3% sevoflurane and rocuronium to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a endobronchial tube or blocker with use of mechanical ventilation.

Intubated thoracoscopic lobectomy

Ming-Hui Hung, MD, MSc

Jin-Shing Chen, MD, PhD

A novel nonintubated thoracoscopic technique is promising to enhance recovery after thoracic surgery. However, the effects of nonintubated technique on specific organ protection in not clear yet. In this randomized trial, the effect of nonintubated technique on lung function protection will be evaluated via PaO2/FiO2 ratio, oxidative stress and inflammatory cytokines serially in lung cancer patients undergoing thoracoscopic lobectomy.

Lung cancer is the leading cause of cancer-related death worldwide. Its incidence is increasingly arising recently. For early-stage non-small cell lung cancer, surgery is the standard treatment that offers best chance of survival. For thoracoscopic lung cancer surgery, tracheal intubation with one-lung ventilation is regarded the standard anesthetic management to establish a safe operating environment. However, complications associated with intubated general anesthesia are not negligible. A novel nonintubated thoracoscopic technique is developing and applied in a variety of thoracic diseases. A previous study showed that nonintubated thoracoscopic lobectomy was feasible and safe in lung cancer patients. Furthermore, nonintubated techniques was also associated with a faster recovery of oral intake, less postoperative complications and shorter hospital stay. The effects of nonintubated thoracoscopic technique on specific organ protection is not clear yet.

The aim of this investigation is to explore the effects of nonintubated thoracoscopic lobectomy on lung function protection in lung cancer patients, comparing with the standard intubated patients as a control. The investigators are going to enrol 82 lung cancer patients and randomize them equally to complete thoracoscopic lobectomy with lymphadenectomy either with a nonintubated technique (n=41) or an intubated technique (n=41). The assessment of lung function will be obtained from serial blood gas analyses using PaO2/FiO2 ratio. Additionally, oxidative stress and inflammatory cytokines will be measured from serial blood samples including 8-isoprostane, malondialdehyde, tumor necrosis factor-α, interleukin-6, interleukin-10, S100-β and neuron specific enolase.

Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection

Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection: A Randomized Controlled Trial

Lung function will be assessed by serial arterial blood gas analyses to obtain oxygenation index (PaO2/FiO2).

Oxidative and systemic inflammatory cytokines will be measured from serial blood samples, including 8-isoprostane (pg/mL), malondialdehyde (nM), tumor necrosis factor-alpha (pg/mL), interleukin-6 (pg/mL), interleukin-10 (pg/mL), S100-beta (pg/mL), and neuron specific enolase (ng/mL).

National Taiwan University Hospital

SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.

CT-based radiation therapy given over 5- 6.5 weeks.

SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung

Single-photon-emission CT scan

Katherina Farr, MD PhD

Eric Hau, MBBS PhD

Azza Khalil, MD, PhD

Line Sparvath

Katherina Farr, MD, PhD

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs. Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer.

The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial.

To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.

Participants, care providers and outcome assessors are blinded

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial

crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder.

Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires

Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire

time from randomization to disease progression at any site or death

time from randomization to death of any cause or last date known alive

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Use of Dual Energy Computed Tomography in Thoracic Radiotherapy Planning.	NCT04863027	Lung Cancer Lung Function D... Radiation Pneum...	Thoracic radiot...	18 Years -	Centre hospitalier de l'Université de Montréal (CHUM)
Effects of Nonintubated Thoracoscopic Lobectomy on Lung Protection	NCT03471884	Non-small Cell ... Lung Function D... Tracheal Intuba...	Nonintubated th... Intubated thora...	20 Years - 99 Years	National Taiwan University Hospital
Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer	NCT04676828	Lung Cancer Radiation-Induc... Radiation Pneum... Pulmonary Disea... Lung Function D...	Single-photon-e...	18 Years -	University of Aarhus
Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer	NCT04676828	Lung Cancer Radiation-Induc... Radiation Pneum... Pulmonary Disea... Lung Function D...	Single-photon-e...	18 Years -	University of Aarhus

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