Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

Lung Cancer Clinical Trial

Official title:

Feasibility Study of the RF Ablation Catheter to Ablate Lung Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03272971
• Other study ID #: Protocol 45
• Status: Terminated
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: October 2019
• Source: Broncus Medical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The feasibility of a RF ablation catheter to bronchoscopically ablate lung tumors, will be evaluated in patients already scheduled for surgical resection.

Description:

This study is a prospective, single-arm, single-center, pilot study of bronchoscopic Radio-Frequency Ablation (RFA) treatment of target lung lesions, prior to surgical tumor resection. Up to ten (10) subjects will be treated at the investigational site.

Subjects identified for this study will be those that have a surgical resection already scheduled as part of their lung cancer treatment. Patients who have consented to participate in this study (enrolled) will undergo screening assessments to evaluate the inclusion criteria associated with their lung cancer and general health. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will be scheduled for RFA treatment.

Prior to RFA, high-resolution computed tomography (HRCT) scans will be used to characterize the lesion and determine the access pathways for ablation. At the time of the RFA procedure, a point-of-entry, along a bronchial wall, is created under an image-guided navigation system. The RFA catheter is advanced down the access path until it reaches the tumor and RF is administered at the prescribed dose. Upon completion of the RFA treatment, the subject is immediately prepared for surgical resection in accordance with their lung cancer standard of care. There are no follow-up visits as part of this study, the subject is excited following surgical resection.

The resected tissue will undergo pathological evaluation for tissue viability.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Proven NSCLC or pulmonary metastases from extra-thoracic primary tumor

• Must be eligible for curative lung resection (lobectomy)

• Tumor/lesion size will be a minimum of 10mm along the minor diameter

• Willing to participate in all aspects of study protocol for duration of the study

• Able to understand study requirements

• Signs informed consent form

Exclusion Criteria:

• Any contraindication to bronchoscopy, for example:

• Untreatable life-threatening arrhythmias.

• Inability to adequately oxygenate the patient during the procedure.

• Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated).

• Recent myocardial infarction.

• Previously diagnosed high-grade tracheal obstruction.

• Uncorrectable coagulopathy

• Known coagulopathy

• Platelet dysfunction or platelet count <100 x 10^3 cells/mm3

• History of major bleeding with bronchoscopy

• Suspected pulmonary hypertension: additional testing required, such as ECG

• Moderate-to-severe pulmonary fibrosis

• Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD):

additional testing and PI consent is required

• Bullae >5cm located within the same lobe of target tumor/lesion

• Any other severe or life-threatening comorbidity that could increase the risk associated with bronchoscopic RFA

• Ongoing systemic infection

• Contraindications to general anesthesia

• Inability to stop anticoagulants or antiplatelet agents prior to procedure as dictated by the protocol

• Prior thoracic surgery on the same side of the lung as the targeted tumor/lesion

• Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study

• Life expectancy of less than one year.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Cancer Metastatic
• Lung Cancer, Non-small Cell
• Lung Neoplasms

Intervention

Device:
• Radio-frequency Ablation
The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Broncus Medical Inc	Uptake Medical Technology, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFA relate AEs/SAEs	The incidence of reported adverse events and serious adverse events related to the RFA procedure	Day 0
Primary	Feasibility - Ablated Tissue	Semi-quantitative scoring of necrotic tissue assessed by histology	Day 0
Primary	Feasibility - Delivery of Ablation	Treatment meets the required procedural steps/requirements per the Operator's Manual and treatment is delivered to the target tumor per the individual patient navigation plan.	Day 0