BORIS - aBlação pOR mIcro-ondaS [Microwave Ablation]

NCT ID: NCT04510714

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-10-01

Brief Summary

Patients with sarcoma and lung metastases have few therapeutic options, with poor response to systemic treatment. Many of them are not eligible to surgical treatments due to the high number and distribution of pulmonary lesions or due to comorbidities, which reduce the survival chances of these individuals. Given the high efficacy and overall increased survival demonstrated by recent studies, the minimally invasive treatments (mainly radiofrequency ablation) have gained ground. Although the microwave ablation is a promising new technique for the treatment of patients with pulmonary metastases, there are few studies in the literature to evaluate the efficacy and safety of this procedure in the above population.

Detailed Description

This study was designed to prospectively evaluate the safety and effectiveness of microwave ablation therapy in the treatment of metastatic lung lesions secondary to sarcoma. This technique has been proven to be successful in producing greater areas of ablation, increasing the chances of success and reducing the possibility of local recurrence, especially when compared to radiofrequency ablation. There will be 60 consecutive patients diagnosed and treated at the oncology clinic at the São Paulo State Cancer Institute that are going to participate in this study, after meeting the inclusion/ exclusion criteria. This number may be increased up to approximately about 20 patients, according to the sample behavior in the initial analysis and follow-up. All patients will be informed about the benefits, risks, complications and limitations related to the procedure and written informed consent will be applied. Patients will also be informed that microwave ablation is a new technology in Brazil, despite the extensive international experience and the results already validated in the medical literature.

Logistic regression will be used to evaluate the success of the microwave ablation according to the characteristics of the lesion before the procedure. Logistic regressions for correlated data will be used to (a) evaluate the success of ablation according to all registered lesion characteristics, i.e., numeric characteristics (including tumor size and location) and categorical characteristics (histopathology of the primary tumor); (b) verify if combinations of two or more features of the lesions pose significant independent predictors for the success of ablation; and (c) construct a model to estimate the probability of success of the microwave ablation based on lesion characteristics before the procedure. The survival of patients will be assessed according to (a) the end result of the procedure (patients will be classified in two groups: an effective ablation group and a non-effective ablation group) and (b) the histopathological nature of the primary tumor. The survival rates will be calculated using the Kaplan-Meier test. The log-rank test (x² value of Cox-Mantel) will be used to determine statistically significant differences between the patients' survival rates. The value of P less than 0.05 will be considered to indicate a statistically significant difference for all analyses. Statistical software (Bias for Windows, version 8.4, Epsilon Verlag, Frankfurt, Germany) will be used.

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave ablation arm

Single arm patients with lung sarcoma metastasis that will be treated with microwave ablation

Group Type: EXPERIMENTAL

Image guided percutaneous microwave ablation

Intervention Type: DEVICE

Lung metastasis from sarcoma will be treated with microwave antennas (SOLERO) and Ablation System and microwave generators (Angiodynamics), with power settings of 35-45W and an average ablation time of 15 minutes (range 10-30 minutes). The ablation time will be recorded for all procedures. The manufacturer's recommendations will be observed in all cases, since it is assured that patients are able to tolerate the total ablation time.

Interventions

Image guided percutaneous microwave ablation

Lung metastasis from sarcoma will be treated with microwave antennas (SOLERO) and Ablation System and microwave generators (Angiodynamics), with power settings of 35-45W and an average ablation time of 15 minutes (range 10-30 minutes). The ablation time will be recorded for all procedures. The manufacturer's recommendations will be observed in all cases, since it is assured that patients are able to tolerate the total ablation time.

Intervention Type: DEVICE

Other Intervention Names

Image guided percutaneous lung metastasis ablation

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years;
• Patients with lung metastases arising from sarcoma;
• Patients who are not eligible for surgery for medical reasons, including limited cardiopulmonary reserve. In this cases we will perform a pulmonary function test (PFT) to determine if the patient can withstand ablation;
• Patients with recurrent metastases after pneumectomy or metastases after surgical resection. In this cases we will perform a PFT to determine if the patient can withstand ablation;
• Patients with pulmonary lesions with dimensions up to 3,0 cm in the largest axial diameter;
• Patients with four or fewer lesions. In cases of bilateral metastases, we will evaluate the treatment of only one lung at a time, with an interval of at least two weeks for the treatment of the contralateral lung, respecting the clinical evolution of the patient.
• Patients with no extrapulmonary metastases or just indolent extrapulmonary disease;
• Patients with prior histopathological confirmation of pulmonary lesions.

Exclusion Criteria

• Patients with primary disease without clinical control;
• Presence of uncontrolled extrapulmonary disease, including lymph node progression;
• Presence of hilar lesions or near the main bronchi;
• Presence of five or more lung lesions and/or lesions larger than 3,0 cm in greatest axial length;
• Presence of tumors infiltrating the chest wall, mediastinal and/or pleural dissemination;
• Patients with severe coagulopathy (international normalized ratio (INR) > 1,5 or lower platelet count to 50000/mm³);
• Patients with chronic obstructive pulmonary disease (COPD) stage III/ IV;
• Patients with septicemia;
• Patients refusing ablation treatment or participation in the study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiodynamics, Inc.

INDUSTRY

Sponsor Role: collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcos Roberto de Menezes, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cancer do Estado de Sao Paulo

Locations

Instituto do Câncer do Estado de São Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Guilherme Lopes Pinheiro Martins, MD

Role: CONTACT

guilherme.martins@hc.fm.usp.br

+551138932000

Lucas Fiore, MD

Role: CONTACT

lucas.fiore@hc.fm.usp.br

+551138932208

Facility Contacts

Guilherme Lopes Pinheiro Martins, Md

Role: primary

References

Vogl TJ, Naguib NN, Gruber-Rouh T, Koitka K, Lehnert T, Nour-Eldin NE. Microwave ablation therapy: clinical utility in treatment of pulmonary metastases. Radiology. 2011 Nov;261(2):643-51. doi: 10.1148/radiol.11101643.

Reference Type: BACKGROUND

PMID: 22012906 (View on PubMed)

Abbas G, Schuchert MJ, Pennathur A, Gilbert S, Luketich JD. Ablative treatments for lung tumors: radiofrequency ablation, stereotactic radiosurgery, and microwave ablation. Thorac Surg Clin. 2007 May;17(2):261-71. doi: 10.1016/j.thorsurg.2007.03.007.

Reference Type: BACKGROUND

PMID: 17626404 (View on PubMed)

Dupuy DE, Mayo-Smith WW, Abbott GF, DiPetrillo T. Clinical applications of radio-frequency tumor ablation in the thorax. Radiographics. 2002 Oct;22 Spec No:S259-69. doi: 10.1148/radiographics.22.suppl_1.g02oc03s259.

Reference Type: BACKGROUND

PMID: 12376615 (View on PubMed)

Wolf FJ, Grand DJ, Machan JT, Dipetrillo TA, Mayo-Smith WW, Dupuy DE. Microwave ablation of lung malignancies: effectiveness, CT findings, and safety in 50 patients. Radiology. 2008 Jun;247(3):871-9. doi: 10.1148/radiol.2473070996. Epub 2008 Mar 27.

Reference Type: BACKGROUND

PMID: 18372457 (View on PubMed)

Dupuy DE, Zagoria RJ, Akerley W, Mayo-Smith WW, Kavanagh PV, Safran H. Percutaneous radiofrequency ablation of malignancies in the lung. AJR Am J Roentgenol. 2000 Jan;174(1):57-9. doi: 10.2214/ajr.174.1.1740057. No abstract available.

Reference Type: BACKGROUND

PMID: 10628454 (View on PubMed)

Simon CJ, Dupuy DE, DiPetrillo TA, Safran HP, Grieco CA, Ng T, Mayo-Smith WW. Pulmonary radiofrequency ablation: long-term safety and efficacy in 153 patients. Radiology. 2007 Apr;243(1):268-75. doi: 10.1148/radiol.2431060088.

Reference Type: BACKGROUND

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Suh R, Reckamp K, Zeidler M, Cameron R. Radiofrequency ablation in lung cancer: promising results in safety and efficacy. Oncology (Williston Park). 2005 Oct;19(11 Suppl 4):12-21.

Reference Type: BACKGROUND

PMID: 16366374 (View on PubMed)

Nakamura T, Matsumine A, Yamakado K, Matsubara T, Takaki H, Nakatsuka A, Takeda K, Abo D, Shimizu T, Uchida A. Lung radiofrequency ablation in patients with pulmonary metastases from musculoskeletal sarcomas [corrected]. Cancer. 2009 Aug 15;115(16):3774-81. doi: 10.1002/cncr.24420.

Reference Type: BACKGROUND

PMID: 19514086 (View on PubMed)

Ding JH, Chua TC, Glenn D, Morris DL. Feasibility of ablation as an alternative to surgical metastasectomy in patients with unresectable sarcoma pulmonary metastases. Interact Cardiovasc Thorac Surg. 2009 Dec;9(6):1051-3. doi: 10.1510/icvts.2009.218743. Epub 2009 Sep 18.

Reference Type: BACKGROUND

PMID: 19767303 (View on PubMed)

Lu Q, Cao W, Huang L, Wan Y, Liu T, Cheng Q, Han Y, Li X. CT-guided percutaneous microwave ablation of pulmonary malignancies: Results in 69 cases. World J Surg Oncol. 2012 May 7;10:80. doi: 10.1186/1477-7819-10-80.

Reference Type: BACKGROUND

PMID: 22564777 (View on PubMed)

Other Identifiers

NP 804/15

Identifier Type: -

Identifier Source: org_study_id