Study of Cryoablation for Metastatic Lung Tumors

NCT01957787 | Completed Results DMC

• 1 other identifier: CUC13-LNG079
• Study Type: interventional
• Target: 131
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Neoplasm Metastasis

Keywords

Metastatic lung tumors; Pulmonary metastatic disease

Outcome Measures

Primary Outcomes (1)

• Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12

  Local tumor control defined as the absence of local treatment failure 12 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.

  Month 1 (Month 3 if Month 1 Data was missing) and Month 12

Secondary Outcomes (1)

• Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect

  Baseline up to 30 days post-cryoablation

Other Outcomes (10)

• Local Tumor Control for Each Index Tumor at Month 18 and Month 24

  Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24

• Overall Participant Survival Post-cryoablation

  Up to Month 24

• Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s)

  Up to Month 24

Study Arms (1)

Cryoablation

EXPERIMENTAL

Participants will undergo a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators. Tumors in both lungs are to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session will not be performed. All participants will receive cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors are to be completed within an 8-week window.

Device: Cryoablation

Interventions

Cryoablation DEVICE

Application of extremely cold temperatures to the identified tumor(s).

Also known as: Cryotherapy, Visual-ICE® Cryoablation System, PresIce® Cryoablation System, SeedNet® Cryoablation System, IceEDGE® 2.4 Cryoablation Needles, IceRod® PLUS Cryoablation Needles, IceSphere™ Cryoablation Needles

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (10)

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

Cancer Treatment Centers of America at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

New York Presbyterian Hospital - Cornell Medical Center

New York, New York, 10065, United States

Location

State University of New York at Stony Brook

Stony Brook, New York, 11794, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Inova Alexandria Hospital CVIR

Alexandria, Virginia, 22304, United States

Location

Institut Bergonié

Bordeaux, Aquitaine, 33070, France

Location

Institut Gustave Roussy

Villejuif, Île-de-France Region, 94805, France

Location

Related Publications (8)

• Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8(1):116-7. doi: 10.1102/1470-7330.2008.0015.

  PMID: 18442957 BACKGROUND

• Ahmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6. doi: 10.2214/AJR.04.1068. No abstract available.

  PMID: 16714662 BACKGROUND

• Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. doi: 10.1016/j.jtcvs.2005.12.051.

  PMID: 16678583 BACKGROUND

• Asimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14. doi: 10.1378/chest.127.6.2007.

  PMID: 15947313 BACKGROUND

• Wang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98. doi: 10.1148/radiol.2351030747.

  PMID: 15798173 BACKGROUND

• Inoue M, Nakatsuka S, Yashiro H, Ito N, Izumi Y, Yamauchi Y, Hashimoto K, Asakura K, Tsukada N, Kawamura M, Nomori H, Kuribayashi S. Percutaneous cryoablation of lung tumors: feasibility and safety. J Vasc Interv Radiol. 2012 Mar;23(3):295-302; quiz 305. doi: 10.1016/j.jvir.2011.11.019. Epub 2012 Jan 20.

  PMID: 22265246 BACKGROUND

• Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9.

  PMID: 22096520 BACKGROUND

• Pusceddu C, Sotgia B, Fele RM, Melis L. CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: a preliminary experience. Eur J Radiol. 2013 May;82(5):e246-53. doi: 10.1016/j.ejrad.2012.12.010. Epub 2013 Feb 8.

  PMID: 23394762 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis; Lung Neoplasms

Interventions

Cryosurgery; Cryotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics

Results Point of Contact

• Title: Sr. Clinical Trial Specialist
• Organization: Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

GalilClinical@bsci.com

651-287-5000

Study Officials

• Thierry de Baere, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

• Matthew Callstrom, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 8, 2013
• Study Start: April 10, 2014
• Primary Completion: March 9, 2017
• Study Completion: August 20, 2018
• Last Updated: July 19, 2021
• Results First Posted: August 28, 2019

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); FR (2)