Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Airway Obstruction

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.

AuroLase Therapy

Glenn Goodrich, PhD

This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy in the treatment of subjects with primary and/or metastatic tumors of the lung where there is airway obstruction. In this study patients will be given a systemic IV infusion of particles and a subsequent escalating dose of laser radiation delivered by optical fiber via bronchoscopy.

Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors

A Pilot Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors

Nanospectra Biosciences, Inc.

Symptoms and General Pathology

Constriction, Pathologic

Respiratory Insufficiency

Respiration Disorders

give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy

give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation

give the cases whose central airway stricture were caused by neoplasm compression stent placement

give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare

use cryotherapy to delete soft neoplasm tissue in the airway

cryotherapy

use argon plasma coagulation to delete hard neoplasm tissue in the airway

argon plasma coagulation

use stent placement to open the airway compressed by out neoplasm

stent placement

use snare to delete polypoid neoplasm tissue in the airway

deletion tumor tissue by snare

Deguang Mu, Ph.D

Yandong Nan, MD

Faguang Jin, Ph.D

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture.

The four techniques are：

* cryotherapy
* argon plasma coagulation
* stent
* snare

Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Changhai Hospital

The First Affiliated Hospital of Guangzhou Medical University

Xinqiao Hospital of Chongqing

China Meitan General Hospital

Micro-Tech (Nanjing) Co., Ltd.

Tang-Du Hospital

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Anesthetics, General

Stenting of central lesion and subsequent standard palliative treatment and dyspnoea symptom control

Standard palliative treatment and standard dyspnoea symptom control.

Patients will undergo arterial blood gas sampling from the radial artery. This will be done by experienced doctors who are highly skilled in this procedure.

Arterial puncture

Blood samples for baseline biochemistry, full blood count, and clotting screen will be taken. In patients additionally providing optional consent blood will be taken for laboratory based basic science research into lung cancer carcinogenesis and pharmacogenetics. Blood will be taken by qualified and experienced nurses, doctors and phlebotomists.

Venepuncture

Patients randomised into the stenting arm will undergo rigid bronchoscopy under general anaesthetic.

General anaesthetic

Patients randomised into the stenting arm will be admitted overnight for the procedure

Inpatient stays

All patients will be asked to complete a 6 minute walking test at baseline and on day 15. Patients randomised into the stent arm (Arm A) will complete a further 6 minute walking test at 24 hours post-stent

Walking test

All patients will undergo spirometry and flow volume loop assessments at baseline and on day 15.

Spirometry & flow volume loop assessment

For patients randomised to stenting and giving additional voluntary consent, 2 pairs of biopsies of tumour tissue, and 1 pair of biopsies of normal airways tissue will be taken for basic scientific research into lung cancer carcinogenesis, and pharmacogenetics.

Biopsy material

Dr Mary O'Brien

Mary O'Brien

To investigate whether the use of airways stents (metal tubes to open and keep open narrowed airways) together with the standard treatment increases the proportion of patients who can complete a 6min walking distance (6MWD) test at 2 weeks +/- 2days in patients with breathlessness due to lung cancer, when compared to standard treatment alone.

Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer

Randomised Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer (RESTORE-AIR)

Royal Marsden NHS Foundation Trust

Subjects will receive Rejuvenair Radial SCT prior to lobectomy.

Metered dose radial spray cryotherapy treatment

RejuvenAir™ Radial Spray Cryotherapy

David Breen, MD

Pallav Shah, MD

Dirk-Jan Slebos, MD

Cryotherapy has a long history of safe use in various medical procedures. RejuvenAir System radial spray cryotherapy is a novel procedure being developed as a treatment for conditions associated with abnormal bronchial function, such as chronic bronchitis. The development of appropriate reliable equipment, definition of therapeutic parameters, and an understanding of the tissue effects of treatment have been established through animal studies. This clinical study is being undertaken to assess the feasibility and safety of the application of a radial metered dose spray cryotherapy in the human airway and to evaluate the treatment depth in human airways. The study design is prospective, open label, single arm multi-center study that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and The Netherlands RejuvenAir System treatment will be performed during preoperative bronchoscopy 0 to 60 days prior to prescheduled lung resection in Subjects requiring lobectomy or pneumonectomy for removal of peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that will be removed, distal to the anticipated margin of resection. Treatment should be at least 1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and examined histologically following surgical resection. Subject participation will be from 1 to 60 days and enrollment is anticipated to take 4-5 months.Total study duration is expected to last approximately 10 months.

The patient population intended to participate in this study are subjects scheduled to undergo lobectomy/pneomonectomy for peripheral lung lesions suspicious for or known to be cancer. The intention is that the spray cryotherapy dosing will be performed at the same surgical session as the intended surgery. Bronchoscopy is routinely performed just prior to the start of the lung resection and it is anticipated that the spray cryotherapy dose will be delivered at that time. Care will be taken to avoid administration of the spray cryotherapy dose at or near the surgical resection margin or near the lung lesion itself.

A secondary endpoint beyond the safety and ease of delivery of the spray cryotherapy dose will be an analysis of the local tissue effect of the spray cryotherapy dose. Given that this area will reside within the anticipated resected surgical specimen, the treatment site will be inspected for evidence of depth of tissue effect using routine hematoxylin and eosin staining and light microscopy evaluation.

RejuvenAir™ System Lobectomy Safety and Histology Study

A Prospective Study of RejuvenAir™ System Radial Spray Cryotherapy to Determine Safety and Histological Effect in the Lung

Safety as measured by occurrence of serious adverse events related to metered dose radial spray cryotherapy treatment performed prior to scheduled lobectomy or pneumonectomy surgery

Description of depth of histological treatment effect per specified treatment dose

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors	NCT01679470	Primary or Meta...	AuroLase Therap...	18 Years -	Nanospectra Biosciences, Inc.
Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors	NCT01679470	Primary or Meta...	AuroLase Therap...	18 Years -	Nanospectra Biosciences, Inc.
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture	NCT02299830	Airway Obstruct...	cryotherapy argon plasma co... stent placement deletion tumor ...	18 Years - 70 Years	Tang-Du Hospital
Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer	NCT01003522	Non-small Cell ...	Arterial punctu... Venepuncture General anaesth... Inpatient stays Walking test Spirometry & fl... Biopsy material	18 Years -	Royal Marsden NHS Foundation Trust
Evaluation of Stents to Open Restricted Airways in Patients With Centrally Placed Non-small Cell Lung Cancer	NCT01003522	Non-small Cell ...	Arterial punctu... Venepuncture General anaesth... Inpatient stays Walking test Spirometry & fl... Biopsy material	18 Years -	Royal Marsden NHS Foundation Trust
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture	NCT02299830	Airway Obstruct...	cryotherapy argon plasma co... stent placement deletion tumor ...	18 Years - 70 Years	Tang-Du Hospital
RejuvenAir™ System Lobectomy Safety and Histology Study	NCT02106143	Lung Neoplasms Airway Obstruct... Lung Cancer	RejuvenAir™ Rad...	21 Years - 75 Years	CSA Medical, Inc.
RejuvenAir™ System Lobectomy Safety and Histology Study	NCT02106143	Lung Neoplasms Airway Obstruct... Lung Cancer	RejuvenAir™ Rad...	21 Years - 75 Years	CSA Medical, Inc.

Spots Global Cancer Trial Database for airway obstruction