A Feasibility Study of Local Effects of Thermal Vapor Ablation of Operable Cancer Lesions in the Lung
Uptake Medical Corporation
10 participants
Apr 1, 2015
Interventional
Conditions
Summary
This feasibility study will determine the local effects of thermal vapour ablation of operable cancer lesions in the lung. Who is it for? You may be eligible to join this study if you are aged 18 to 75 years and have been diagnosed with non-small cell lung or metastatic lung cancer suitable for resection. Study details: All participants will receive one treatment of thermal vapour ablation via a bronchoscopy procedure before undergoing surgical lung resection within 3 days of the thermal vapour ablation treatment. Resected tissue will be examined to determine effectiveness of treatment. Participants will be followed-up according to standard lung resection procedures. Official study follow up is completed once the resection occurs but patients will be monitored for Adverse Events in the standard lung resection follow up procedure, in order to determine efficacy, safety and feasibility of the study.
Eligibility
Inclusion Criteria12
- Older than or equal to 18 years old
- Less than or equal to 75 years old
- 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
- A suitable candidate for resection as per standard of practice at the surgical
- center.
- 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
- Signed informed consent forms
Exclusion Criteria12
- Suspected stage III or IV disease (if primary lung cancer)
- Pretreatment chemotherapy or radiation therapy for targeted lesion
- Pretreatment chemotherapy or radiation therapy for other lung related reasons <6
- months prior
- Preoperative proof of malignancy not obtained
- Centralized tumor not amenable to lobectomy
- Any condition that in the opinion of the Investigator may interfere with the safety
- of the patient or evaluation of the study objectives
- Receiving >20 mg daily prednisone dose
- Pregnant or breastfeeding
- Any tumor characteristic that in the opinion of the Investigator may interfere with
- the safety of the patient or evaluation of the study objectives
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Interventions
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.
Locations(2)
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ACTRN12615000287538