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Study of Cryoablation for Metastatic Lung Tumors

Overview

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.

Participation eligibility

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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.

Exclusion Criteria:

  • 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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

David Woodrum, M.D., Ph.D.

Closed for enrollment

More information

Publications

  • To report the data of our initial experience with CT-guided thin cryoprobes for percutaneous cryoablation (PCA) in patients with primary and secondary pulmonary tumors. Read More on PubMed
  • To evaluate the safety and feasibility of cryoablation for lung tumors as well as the incidence of, and risk factors for, complications. Read More on PubMed
  • To evaluate the safety and efficacy of cryoablation for metastatic lung tumors from colorectal cancer. Read More on PubMed
  • Ablation of lung tumours is the fastest expanding area within interventional oncology. Radiofrequency, laser, microwave and cryotherapy have all been shown to be effective. Which of these ablation technologies becomes the preferred technique for lung tumours remains to be seen. Read More on PubMed
  • Cryoablation of pulmonary metastases might be a useful therapy for nonsurgical candidates. Read More on PubMed
  • More than 80% of patients with lung cancer are unsuitable for curative surgical treatment. Palliative relief of symptoms, often caused by airway obstruction, is very important. Endobronchial cryosurgery is used for destruction of intraluminal tumors. This study analyzes the effects of cryosurgery on patients with obstructive endobronchial carcinoma. Read More on PubMed
  • To perform and report initial experience with percutaneous cryotherapy (PCT) of the thorax. Read More on PubMed

More about research at Mayo Clinic

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CLS-20112008

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