A Feasibility Study of Local Effects of Thermal Vapor Ablation of Operable Cancer Lesions in the Lung

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000287538
• Date of registration: 26/03/2015
• Prospective Registration: Yes
• Primary sponsor: Uptake Medical Corporation
• Public title: A Feasibility Study of Local Effects of Thermal Vapor Ablation of Operable Cancer Lesions in the Lung
• Scientific title: A Feasibility Study of Local Effects of Thermal Vapor Ablation of Operable Cancer Lesions in the Lung
• Date of first enrolment: 01/04/2015
• Target sample size: 10
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12615000287538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 1

Countries of recruitment

Australia, Austria

Contacts

• Name: Mr Erik Henne

• Name: Ms Lynda Holsworth

Key inclusion & exclusion criteria

Inclusion criteria: Older than or equal to 18 years old
Less than or equal to 75 years old
2. Diagnosis of non-small cell lung cancer tumor less than or equal to 3 cm (T1N0 or T1N1) suitable for
resection
OR
Metastatic lung tumor less than or equal to 3cm suitable for resection
3. A suitable candidate for resection as per standard of practice at the surgical
center.
4. Location of tumor such that:
a. Resection would remove all gross tumor and ablation with grossly negative margins
b. Maximum of three vapor ablation applications would target entire margin
5. Signed informed consent forms

Exclusion criteria: 1. Suspected stage III or IV disease (if primary lung cancer)
2. Pretreatment chemotherapy or radiation therapy for targeted lesion
3. Pretreatment chemotherapy or radiation therapy for other lung related reasons <6
months prior
4. Preoperative proof of malignancy not obtained
5. Centralized tumor not amenable to lobectomy
6. Any condition that in the opinion of the Investigator may interfere with the safety
of the patient or evaluation of the study objectives
7. Receiving >20 mg daily prednisone dose
8. Pregnant or breastfeeding
9. Any tumor characteristic that in the opinion of the Investigator may interfere with
the safety of the patient or evaluation of the study objectives

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancerous lung lesions;
Cancerous lung lesions

Cancer - Lung - Non small cell

Intervention(s)

Thermal Vapor ablation delivered to target lung areas (Cancerous Lesions).
One dose of 330 calories of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior to lung resection.
Lung resection will then occur according to the standard hospital procedures.
The first two patients will have lung resection on the same day as the bronchoscopic delivery of Vapor. Subsequent patients will have lung resection performed up to 3 days post bronchoscopic delivery of vapour.

Primary Outcome(s)

To establish and confirm initial insight into the efficacy of the Uptake Medical Corp. TVA-LL system for ablation of primary and secondary cancer lesions in the lung.
Efficacy will be assessed by tissue staining being performed to assess tissue viability. [Tissue staining for viability will be performed in the period after surgical resection in alignment with standard pathology testing in post surgical resection patients.]

To establish and confirm initial insight into the safety of the Uptake Medical Corp. TVA-LL system for ablation of primary and secondary cancer lesions in the lung.
Safety will be measured by assessing the occurrence of all adverse events (serious and non-serious)
secondary to the thermal vapor ablation treatment from initiation of vapour ablation treatment through to the point of surgical resection.[From the period of initiation of thermal vapor ablation to the point of surgical resection.]

To establish and confirm initial insight into the feasibility of the Uptake Medical Corp. TVA-LL system for ablation of primary and secondary cancer lesions in the lung.
Feasibility will be assessed by evaluating that the thermal vapour ablation procedure can be successfully delivered with the equipment available in the bronchoscopy suite.[At the conclusion of the delivery of thermal vapour ablation in the bronchoscopy suite.]

Secondary Outcome(s)

Characterisation of adjacent tissue effect from imaging (if taken)[To be analysed in the period following thermal vapour ablation just prior to surgical resection (in interval patients if CT option taken by clinician)]

Characterisation of the necrotic region via imaging (if taken - optional to clinician discretion)[To be analysed in the period following thermal vapour ablation just prior to surgical resection (in interval patients if CT option taken by clinician)]

Gross observation of ablated tissue.[At the conclusion of the tissue staining and analysis process]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Uptake Medical Corporation

Secondary Sponsor(s)

Aurora Bioscience Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

The Alfred Hospital