Study of Cryoablation for Metastatic Lung Tumors
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-007655
NCT ID: NCT01957787
Sponsor Protocol Number: CUC13-LNG079
About this study
The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in patients with pulmonary metastatic disease. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5cm. Patients will be followed 24 months post their cryoablation procedure.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patient must be at least 18 years old.
- Patient has signed a written informed consent.
- Patient presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy; or Patient presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (e.g. computerized tomography or CT) with histology proven primary cancer.
- Patient has up to 6 local pulmonary metastases targetable by cryoablation.
- Targeted index tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm, measured in the longest cross sectional dimension.
- The target index tumor(s) is determined (by CT images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs/ structures and is greater than 0.5 cm from any critical organ/structure (possibly achieved with additional maneuvers such as iatrogenic pneumothorax or hydrodissection).
- Karnofsky Performance Scale (KPS) score greater than or equal to 60.
- Platelet count greater than 50,000/mm3 within 8 weeks prior to initial cryoablation procedure.
- International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure.
- Patient has a life expectancy of greater than 3 months.
- Patient's index tumor(s) is primary lung cancer.
- Patient has uncontrollable primary or metastatic disease outside of the lung.
- Patient is unable to lie flat or has respiratory distress at rest.
- Patient has a coagulopathy or bleeding disorder which is uncontrolled.
- Absolute Neutrophil Count (ANC) <1000 within 8 weeks prior to initial cryoablation procedure.
- Patient has evidence of active systemic, pulmonary, or pericardial infection.
- Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
- Patient is currently participating in other experimental studies that could affect the primary endpoint (e.g. experimental chemotherapy regimen).
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.