CompletedNot applicableNCT01957787

Study of Cryoablation for Metastatic Lung Tumors

The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.

Checked against the public recordLast updated Jul 19, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations10
SponsorBoston Scientific Corporation
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Boston Scientific Corporation
Interventions being studied
Device: Cryoablation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Participant must be at least 18 years old. * Participant has signed a written informed consent. * Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy; or Participant presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (for example, computerized tomography or CT) with histology proven primary cancer. * Participant 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/millimeters (mm)\^3 within 8 weeks prior to initial cryoablation procedure. * International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure. * Participant has a life expectancy of greater than 3 months. Exclusion Criteria: * Participant's index tumor(s) is primary lung cancer. * Participant has uncontrollable primary or metastatic disease outside of the lung. * Participant is unable to lie flat or has respiratory distress at rest. * Participant has a coagulopathy or bleeding disorder which is uncontrolled. * Absolute Neutrophil Count (ANC) \<1000 within 8 weeks prior to initial cryoablation procedure. * Participant has evidence of active systemic, pulmonary, or pericardial infection. * Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up. * Participant is currently participating in other experimental studies that could affect the primary endpoint (for example, experimental chemotherapy regimen).

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCLA Ronald Reagan Medical CenterLos Angeles, California
  • Cancer Treatment Centers of America at Southeastern Regional Medical CenterNewnan, Georgia
  • Mayo Clinic RochesterRochester, Minnesota
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • New York Presbyterian Hospital - Cornell Medical CenterNew York, New York
  • State University of New York at Stony BrookStony Brook, New York
  • Rhode Island HospitalProvidence, Rhode Island
  • Inova Alexandria Hospital CVIRAlexandria, Virginia
  • Institut BergoniéBordeaux, Aquitaine
  • Institut Gustave RoussyVillejuif, Île-de-France Region

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 19, 2021. Always confirm current availability with the study team.

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