BORIS - aBlação pOR mIcro-ondaS [Microwave Ablation]

NCT04510714 | Unknown DMC FDA Device

• 1 other identifier: NP 804/15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

Sarcoma; Percutaneous ablation; Lung ablation; Microwave ablation

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Patients with sarcoma pulmonary metastases who are treated with microwave ablation of lung lesions may have higher overall survival rates compared to patients not subject to any kind of treatment or even chemotherapy/ palliative treatment. The literature contains data favorable to treating these patients with microwave ablation, since higher survival rates have been observed, especially when handled all lung lesions (R0).

  3 years

Study Arms (1)

Microwave ablation arm

EXPERIMENTAL

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

Device: Image guided percutaneous microwave ablation

Interventions

Image guided percutaneous microwave ablation 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.

Also known as: Image guided percutaneous lung metastasis ablation

Microwave ablation arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Angiodynamics, Inc.: collaborator

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, 01246-000, Brazil

RECRUITING

Related Publications (10)

• 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.

  PMID: 22012906 BACKGROUND

• 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.

  PMID: 17626404 BACKGROUND

• 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.

  PMID: 12376615 BACKGROUND

• 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.

  PMID: 18372457 BACKGROUND

• 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.

  PMID: 10628454 BACKGROUND

• 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.

  PMID: 17392258 BACKGROUND

• 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.

  PMID: 16366374 BACKGROUND

• 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.

  PMID: 19514086 BACKGROUND

• 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.

  PMID: 19767303 BACKGROUND

• 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.

  PMID: 22564777 BACKGROUND

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Marcos Roberto de Menezes, MD, PHD

  Instituto do Cancer do Estado de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guilherme Lopes Pinheiro Martins, MD

CONTACT

+551138932000; guilherme.martins@hc.fm.usp.br

Lucas Fiore, MD

CONTACT

+551138932208; lucas.fiore@hc.fm.usp.br

Study Design

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

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: June 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)