Microwave Ablation in Pulmonary Malignancies

NCT04081181 | Unknown

• 1 other identifier: MWAL
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lung cancer remains to be an important global issue as it is the leading cause of cancer\_ related mortality for both men and women worldwide .Since more than two thirds of cases are diagnosed at an advanced stage,the survival rate of lung cancer is one of the lowest among all cancers.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Percentage of patients achieving adequacy of ablation

  Defined as perilesional circumferential solid area of ground glass opacification of \>4mm

  24 hours post ablation

• Percentage of patients achieving technical efficacy

  Defined as lack of enhancement within the ablated zone

  1 month after ablation

• Local progression free survival

  The interval between microwave ablation and evidence of local recurrence. Local recurrence defined as enlargement of the zone , the development of contrast enhancement in the part of the zone or change in the size of the ablated zone as a result if enlargement of one area.

  From the date of ablation up to six months

Secondary Outcomes (1)

• Adverse events

  From the date of ablation up to six months follow up

Study Arms (1)

CT_ guided percutaneous microwave ablation

EXPERIMENTAL

The procedure will be done under anaesthesia by interventional radiologist

Procedure: Microwave ablation

Interventions

Microwave ablation PROCEDURE

CT\_guided Microwave ablation is a minimally invasive technique that kill the insitu lung cancer cells, produce large volumes of cellular necrosis with reduced procedure time .According to the preoperative CT image of the patient , we will determine the focal position of the lesion ,it's size and it's relationship with adjacent organs to choose the optimal puncture point , puncture path and proper microwave antenna and to set the power and time of ablation.Then under the guidance of CT , the tip of antenna will be sent into the focus by puncture with ablation power of 60\_80 W .according to tumor size , the ablation time will be determined.Needle track coagulation will be done to prevent seeding of malignant cells. After ablation a CT scan will be done immediately to observe the size ,shape and relation to nearby organ of the lesion and to determine if there is pneumothorax

CT_ guided percutaneous microwave ablation

Eligibility Criteria

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

You may qualify if:

• patient has good compliance and sign the informed consent.
• patient with lung cancer who lost the opportunity of surgical resection.
• patient has one or more metastatic lung nodules (not more than 5)

You may not qualify if:

• patient is pregnant or breast feeding .
• patient with uncorrectable coagulopathy.
• There are large blood vessels or important structures adjacent to lung lesion.
• patient with more than five nodules

Sponsors & Collaborators

• Assiut University: lead

Related Publications (13)

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

  PMID: 25220842 BACKGROUND

• Jahangeer S, Forde P, Soden D, Hinchion J. Review of current thermal ablation treatment for lung cancer and the potential of electrochemotherapy as a means for treatment of lung tumours. Cancer Treat Rev. 2013 Dec;39(8):862-71. doi: 10.1016/j.ctrv.2013.03.007. Epub 2013 Apr 17.

  PMID: 23601905 BACKGROUND

• Weiser MR, Downey RJ, Leung DH, Brennan MF. Repeat resection of pulmonary metastases in patients with soft-tissue sarcoma. J Am Coll Surg. 2000 Aug;191(2):184-90; discussion 190-1. doi: 10.1016/s1072-7515(00)00306-9.

  PMID: 10945362 BACKGROUND

• Smith R, Pak Y, Kraybill W, Kane JM 3rd. Factors associated with actual long-term survival following soft tissue sarcoma pulmonary metastasectomy. Eur J Surg Oncol. 2009 Apr;35(4):356-61. doi: 10.1016/j.ejso.2008.01.004. Epub 2008 Feb 21.

  PMID: 18294807 BACKGROUND

• Zhong L, Sun S, Shi J, Cao F, Han X, Bao X, You Q. Clinical analysis on 113 patients with lung cancer treated by percutaneous CT-guided microwave ablation. J Thorac Dis. 2017 Mar;9(3):590-597. doi: 10.21037/jtd.2017.03.14.

  PMID: 28449467 BACKGROUND

• Bonichon F, Godbert Y, Gangi A, Buy X, Palussiere J. PET/Computed Tomography and Thermoablation (Radiofrequency, Microwave, Cryotherapy, Laser Interstitial Thermal Therapy). PET Clin. 2015 Oct;10(4):519-40. doi: 10.1016/j.cpet.2015.05.008. Epub 2015 Aug 1.

  PMID: 26384598 BACKGROUND

• Shahzad Y, Louw R, Gerber M, du Plessis J. Breaching the skin barrier through temperature modulations. J Control Release. 2015 Mar 28;202:1-13. doi: 10.1016/j.jconrel.2015.01.019. Epub 2015 Jan 20.

  PMID: 25616160 BACKGROUND

• Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.

  PMID: 16227498 BACKGROUND

• Carrafiello G, Lagana D, Mangini M, Fontana F, Dionigi G, Boni L, Rovera F, Cuffari S, Fugazzola C. Microwave tumors ablation: principles, clinical applications and review of preliminary experiences. Int J Surg. 2008;6 Suppl 1:S65-9. doi: 10.1016/j.ijsu.2008.12.028. Epub 2008 Dec 14.

  PMID: 19186116 BACKGROUND

• Cheng M, Fay M, Steinke K. Percutaneous CT-guided thermal ablation as salvage therapy for recurrent non-small cell lung cancer after external beam radiotherapy: A retrospective study. Int J Hyperthermia. 2016 May;32(3):316-23. doi: 10.3109/02656736.2015.1137640. Epub 2016 Feb 19.

  PMID: 26892261 BACKGROUND

• Pacella CM, Papini E. Image-guided percutaneous ablation therapies for local recurrences of thyroid tumors. J Endocrinol Invest. 2013 Jan;36(1):61-70. doi: 10.1007/BF03346744.

  PMID: 23391859 BACKGROUND

• Anderson EM, Lees WR, Gillams AR. Early indicators of treatment success after percutaneous radiofrequency of pulmonary tumors. Cardiovasc Intervent Radiol. 2009 May;32(3):478-83. doi: 10.1007/s00270-008-9482-6. Epub 2009 Jan 6.

  PMID: 19127381 BACKGROUND

• Chheang S, Abtin F, Guteirrez A, Genshaft S, Suh R. Imaging Features following Thermal Ablation of Lung Malignancies. Semin Intervent Radiol. 2013 Jun;30(2):157-68. doi: 10.1055/s-0033-1342957.

  PMID: 24436532 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mostafa Ahmed Mamdouh El_Sharkawy, Prof.Dr

CONTACT

01223971443; Drmostafamri@yahoo.com

Shereen Ezzat, Dr

CONTACT

01062994299; Shereenezzat961@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: July 15, 2020
• Primary Completion: May 13, 2022
• Study Completion: August 12, 2022
• Last Updated: June 25, 2020

Record last verified: 2020-06