Neoplasm MetastasisSOLSTICENCT01957787
Study of Cryoablation for Metastatic Lung Tumors
A study testing Cryoablation in people with Neoplasm Metastasis, run by Boston Scientific Corporation at 10 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 10 Apr 2014to 20 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Inova Alexandria Hospital CVIR
Alexandria, Virginia, 22304
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
New York Presbyterian Hospital - Cornell Medical Center
New York, New York, 10065
Cancer Treatment Centers of America at Southeastern Regional Medical Center
Newnan, Georgia, 30265
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic Rochester
Rochester, Minnesota, 55905
State University of New York at Stony Brook
Stony Brook, New York, 11794
France2 sites
Institut Bergonié
Bordeaux, Aquitaine, 33070
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94805
About this study
Official title: Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation
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.
Read the detailed description
Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation therapy, or a combination of treatments. However, several variables may exclude participants from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these participants, percutaneous cryoablation may be a suitable option.
Ablation of metastatic lung tumors is a rapidly expanding area within interventional oncology. Cryotherapy, radiofrequency, laser, and microwave have all been shown to be effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of the ability to visualize the ice under imaging guidance and the preservation of collagenous tissue structure. Cryoablation has been extensively performed in the prostate and kidney with favorable outcomes reported in the literature. More recently, cryoablation has been shown to be safe in the treatment of lung tumors with CT guidance.
- Conditions
- Neoplasm Metastasis
- Being tested
- Cryoablation
- Keywords
- Metastatic lung tumors, Pulmonary metastatic disease
- Medical subject headings
- Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Also called Cryotherapy, Visual-ICE® Cryoablation System, PresIce® Cryoablation System, SeedNet® Cryoablation System
Application of extremely cold temperatures to the identified tumor(s).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The number of participants with the following categories of adverse events is presented: an intra-operative, a post-operative, a serious adverse event, or an unanticipated adverse device effect. The adverse events that are presented are related to the cryoablation procedure. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline up to 30 days post-cryoablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start10 Apr 2014
- Primary completion9 Mar 2017
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry de Baere, MD, Study chair, Gustave Roussy, Cancer Campus, Grand ParisMatthew Callstrom, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957787
- Sponsor's protocol ID
- CUC13-LNG079
- Acronym
- SOLSTICE
- Status last verified
- Jul 2021
- First submitted
- 4 Oct 2013
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18442957Ahmed 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.
PubMed 16714662Kawamura 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.
PubMed 16678583Asimakopoulos 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.
PubMed 15947313Wang 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.
PubMed 15798173Inoue 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.
PubMed 22265246Yamauchi 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.
PubMed 22096520Pusceddu 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.
PubMed 23394762
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation
- ClinicalTrials.gov ID
- NCT01957787
- Acronym / sponsor ID
- SOLSTICE / CUC13-LNG079
- Conditions
- Neoplasm Metastasis
- Keywords
- Metastatic lung tumors, Pulmonary metastatic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation therapy, or a combination of treatments. However, several variables may exclude participants from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these participants, percutaneous cryoablation may be a suitable option.
Ablation of metastatic lung tumors is a rapidly expanding area within interventional oncology. Cryotherapy, radiofrequency, laser, and microwave have all been shown to be effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of the ability to visualize the ice under imaging guidance and the preservation of collagenous tissue structure. Cryoablation has been extensively performed in the prostate and kidney with favorable outcomes reported in the literature. More recently, cryoablation has been shown to be safe in the treatment of lung tumors with CT guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | Experimental | Device: CryoablationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationAlso: Cryotherapy, Visual-ICE® Cryoablation System, PresIce® Cryoablation System, SeedNet® Cryoablation SystemApplication of extremely cold temperatures to the identified tumor(s). | Device | Cryoablation |
Primary outcome
Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12
Time frame: Month 1 (Month 3 if Month 1 Data was missing) and 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.
1 secondary outcome
Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect
Time frame: Baseline up to 30 days post-cryoablation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18442957Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8(1):116-7. doi: 10.1102/1470-7330.2008.0015.
- Background: PubMed 16714662Ahmed 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.
- Background: PubMed 16678583Kawamura 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.
- Background: PubMed 15947313Asimakopoulos 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.
- Background: PubMed 15798173Wang 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.
- Background: PubMed 22265246Inoue 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.
- Background: PubMed 22096520Yamauchi 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.
- Background: PubMed 23394762Pusceddu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry de Baere, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
Matthew Callstrom, MD study chair
Mayo Clinic
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Neoplasm Metastasis, run by Boston Scientific Corporation at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12 (time frame: Month 1 (Month 3 if Month 1 Data was missing) and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01957787, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.