Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

Official title

Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK

Overview

This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, the investigators are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours. The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure. The study, funded by Creo Medical, will be conducted at sites in the UK and Italy, and will involve up to 18 participants.

Detailed description

Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation.

There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital.

Participation in this study has the potential to provide the following benefits for other people who have the same medical condition:

* The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure. * Shorter patient recovery times. * Reduced incidence of complications.

Interventions

• Device Ablation
  Bronchoscopy and microwave ablation of the lung tumour prior to surgical resection.

Primary outcome measures

• Safety of the MicroBlate Flex AB1 system in lung tumour ablation [Time frame: Up to 21 days after the ablation procedure]
• Technical Success and Performance of the AB1 instrument [Time frame: Up to 28 days post ablation procedure]

Secondary outcome measures (4)

• Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion [Time frame: Up to 1 week post surgical resection procedure]
• Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT [Time frame: Up to 1 week post ablation procedure]
• Procedural Time [Time frame: Up to 1 week post ablation procedure]
• Assessment of ease of system use (Clinician Questionnaires) [Time frame: Up to 1 week post ablation procedure]

Eligibility criteria

Inclusion criteria

Patients who:

• Have signed informed consent.
• Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
• Are ≥ 18 years old.
• Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
• Have soft tissue lung lesion(s):

• ≤ 20 mm in the largest dimension of the pulmonary window
• Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
• > 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
• Subject is willing and able to comply with the study protocol requirements.
• Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.

Exclusion criteria

Patients who:

• Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic \& laryngeal nerves).
• Are pregnant or breast feeding, as determined by standard site practices.
• Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
• Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
• Have an expected survival less than 12 months.
• Have an implantable device, including pacemakers or other electronic implants.
• Have known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] >50mmHg).
• Subject had a prior pneumonectomy.
• Diagnosis of Small Cell Lung Cancer.
• Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
• Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Istituto Europeo di Oncologia (IEO), Via Ripamonti 435 — Milan

United Kingdom · 1 center

• Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital, Sydney Street — London

Publications

• Chang et al The Lancet Oncology 2015 Vol 16, Issue 6, 630 - 637
• SABR UK Consortium. "Stereotactic Ablative Body Radiation Therapy (SABR): A Resource." Version 6.1. January 2019.
• Chen H, Senan S, Nossent EJ, Boldt RG, Warner A, Palma DA, Louie AV. Treatment-Related Toxicity in Patients With Early-Stage Non-Small Cell Lung Cancer and Coexisting Interstitial Lung Disease: A Systematic Review. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):622-631. doi: 10.1016/j.ijrobp.2017.03.010. Epub 2017 Mar 15. PMID 28581404
• Boffa DJ, Allen MS, Grab JD, Gaissert HA, Harpole DH, Wright CD. Data from The Society of Thoracic Surgeons General Thoracic Surgery database: the surgical management of primary lung tumors. J Thorac Cardiovasc Surg. 2008 Feb;135(2):247-54. doi: 10.1016/j.jtcvs.2007.07.060. Epub 2007 Dec 21. PMID 18242243
• Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thorac Surg. 2006 May;81(5):1830-7. doi: 10.1016/j.athoracsur.2005.11.048. PMID 16631680
• Covey AM, Gandhi R, Brody LA, Getrajdman G, Thaler HT, Brown KT. Factors associated with pneumothorax and pneumothorax requiring treatment after percutaneous lung biopsy in 443 consecutive patients. J Vasc Interv Radiol. 2004 May;15(5):479-83. doi: 10.1097/01.rvi.0000124951.24134.50. PMID 15126658

Identifiers

NCT: NCT06869122 · PD-GTD-AB1UK-003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗