Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients meeting the inclusion criteria will be enrolled in the study and undergo ENB guided MWA. Chest CT will be performed at 1 day after the procedure to confirm the complications and then at 1 month, every 3 months for 2 years, and every 6 months for 3 years thereafter after the procedure. PET/CT will be performed 3 months after MWA to assess the treatment response.

Patients diagnosed with early-stage NSCLC and signing the informed consent will undergo MWA with the guidance of ENB.

ENB (LungCare Medical Technologies Ltd., Inc, Suzhou, China)will be used to guide bronchoscope into the accurate location of the lesion during MWA.

Jiayuan Sun, MD, PhD

Jiayuan Sun, MD,PhD

The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided microwave ablation (MWA) for the treatment of early-stage peripheral lung cancer.

The study is designed as a multi-center prospective trial with one arm. There will be 5 centers participating the study. Patients diagnosed with early-stage non-small cell lung cancer (NSCLC) that are nonsurgical candidate will be enrolled in the study. Sixty patients are expected to be enrolled in the study. The purpose of the study is to evaluate the efficacy and safety of ENB guided MWA for the treatment of patients with early-stage nonsurgical NSCLC.

ENB Guided MWA for Early-stage Peripheral Lung Cancer

A Multi-center Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Microwave Ablation for Early-stage Peripheral Lung Cancer

Tumor response will be evaluated at 3 months after ablation. Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.

Disease progression is evaluated based on the changes of the tumor on computed The arrival rate is the proportion of the locatable wire reaching the location of the tumor accurately.

Disease progression is evaluated based on the changes of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria.

Overall survival（OS) is evaluated after the treatment of ablation until the patient death.

Complications refer to serious operation-related adverse events during and after the operation, such as pneumothorax, bleeding and infection.

Shanghai Chest Hospital

Director, Department of Respiratory Endoscopy

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Central Nervous System Depressants

Ethiodized Oil

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Ether

Photosensitizing Agents

High refraction-index contrast medium: Lipiodol injected in the bronchial tree can enhance the treatment extension of the photodynamic therapy

Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.

Porfimer sodium

In hybrid operation room setting, a navigational bronchoscope guide sheath was inserted to the proximal end of the tumor region. About 5 ml Lipiodol was infused to full cover whole the tumor.

Ethiodized oil

Using high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy

Novel light delivery methods of photodynamic therapy

A cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy.

Fiber optic

Yei-San Hsieh, MD

Hwailuh Chang, MD

This research study is being conducted to assess the safety and feasibility of using a newly developed bronchoscopic light delivery method of photodynamic therapy to treat subjects with solid tumors in peripheral lung, who are inoperable or refused surgery.

Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy in a hybrid operation room) have been shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain a diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal area using a fiber-optic device (very fine fiber \[like a fishing line\] that permits light transmission) inserted into a flexible tube called a bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction. But the penetrating depth of light is about 1.5 to 2 cm limits the treatment range of tumor size.

We proposed a novel light delivery method of instilling a high-refractive-index (RI) liquid (Lipiodol) to enhance light delivery in the lung.

The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electro-navigational bronchoscopy in a hybrid operation room and inject the lipiodol to cover the whole tumor then deliver photodynamic therapy by placing the optical fiber into the tumor

Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study

Single Center, Prospective, Open Label, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Lipiodol® as a Light Deliver and Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung

Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.

The incidence of adverse events following Novel PDT will be presented as the primary safety indicator for this treatment.

From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

Taoyuan General Hospital

Patients with early-stage peripheral lung cancer will be performed RFA with the guidance of ENB. Post treatment response and follow up will be evaluated and carried out according to the standard procedure.

Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.

ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.

The objective of the study was to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy (ENB) guided radiofrequency ablation (RFA) for the treatment of early-stage peripheral lung cancer.

The study is aimed to evaluate the efficacy and safety of ENB guided RFA for the treatment of patients with early-stage non-small cell lung cancer (NSCLC). The study is designed as a single-center prospective trial with one arm. The participating centers are Department of pulmonary medicine and endoscopy, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University, China. Patients diagnosed with early-stage NSCLC will be enrolled into the study. Fifty patients are expected to be enrolled totally.

ENB Guided RFA for Early-stage Peripheral Lung Cancer

The Clinical Study of Electromagnetic Navigation Bronchoscopy (ENB) Guided Radiofrequency Ablation (RFA) for the Treatment of Early-stage Peripheral Lung Cancer

Complications refer to serious operation-related adverse events during and after the operation,such as pneumothorax, bleeding and infection.

Objective response rate（ORR） is the proportion of patients with complete responses and partial responses according to the modified RECIST criteria.

Disease progression is evaluated by the variation of the tumor on computed tomography (CT) and/or positron emission tomography/computed tomography (PET/CT) according to modified RECIST criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ENB Guided MWA for Early-stage Peripheral Lung Cancer	NCT04005157	Lung Cancer	MWA ENB	18 Years -	Shanghai Chest Hospital
Novel Light Delivery Methods for Lung Cancer Photodynamic Therapy - A Pilot Study	NCT04753918	Non-small Cell ... Lung Metastasis	Porfimer sodium Ethiodized oil Novel light del... Fiber optic	20 Years - 75 Years	Taoyuan General Hospital
ENB Guided RFA for Early-stage Peripheral Lung Cancer	NCT03009630	Lung Cancer	RFA ENB	18 Years -	Shanghai Chest Hospital
ENB Guided MWA for Early-stage Peripheral Lung Cancer	NCT04005157	Lung Cancer	MWA ENB	18 Years -	Shanghai Chest Hospital

Spots Global Cancer Trial Database for peripheral lung cancer