Microwave Ablation in Pulmonary Malignancies

NCT ID: NCT04081181

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-08-12

Brief Summary

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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.

Detailed Description

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Currently , Surgery is one of the curative treatment option for primary lung cancer but most patients are either diagnosed at an advanced stage or are unfit for surgery due to medical co\_morbidities or poor underlying lung reserve , less than a third of all lung cancer patients can undergo surgical resection .

Lung metastasectomy is considered a therapeutic option increasing the survival rate for patients of pulmonary metastases but only 25%\_30% of patients benefits from lung metastasectomy due to multiplicity of pulmonary nodules or medical co\_ morbidities .

In spite of a significant improvement of lung cancer chemotherapy and radiotherapy in recent years , the overall clinical outcome is less than satisfactory compared with that brought by surgical resection .Thus , it is urgent to provide a method which is more effective than chemotherapy and radiotherapy and nearly effective as the surgical treatment for the patients who are not eligible for surgery.

Local thermal ablation therapy of the tumor is the focus of recent research in the past decades .This method is to deliver specific energy into the tumor tissue under the guidance of image technology , which make the local tissue quickly reach 60°C where an irreversible coagulative necrosis happens leading to necrosis of tumor cells .

CT\_guided Microwave ablation is a minimally invasive technique that may be an alternative treatment option for management of lung cancer in patients who are not candidate for surgery .This method not only kill the insitu lung cancer cells , but also protect lung cancer tissue .It can produce large volumes of cellular necrosis with reduced procedure time , can use multiple antennae and can be used in lesions with cystic component and/or in proximity to vascular structures.

Thus, CT guided microwave ablation is a promising new technique that is convenient ,easy ,causing less trauma ,associated with no need for general anaesthesia , fast recovery and less complications.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CT_ guided percutaneous microwave ablation

The procedure will be done under anaesthesia by interventional radiologist

Group Type EXPERIMENTAL

Microwave ablation

Intervention Type 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

Interventions

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Microwave ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Reham M Farghally

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mostafa Ahmed Mamdouh El_Sharkawy, Prof.Dr

Role: CONTACT

01223971443

Shereen Ezzat, Dr

Role: CONTACT

01062994299

References

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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.

Reference Type BACKGROUND
PMID: 25220842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23601905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10945362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18294807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28449467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26384598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25616160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16227498 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19186116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26892261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23391859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19127381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24436532 (View on PubMed)

Other Identifiers

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MWAL

Identifier Type: -

Identifier Source: org_study_id

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