Lung CancerNCT04081181
Microwave Ablation in Pulmonary Malignancies
A study testing Microwave ablation in people with Lung Cancer, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Microwave ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2020to 12 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: CT_ Guided Percutaneous Microwave Ablation in Treatment of Pulmonary Malignancies
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.
Read the detailed description
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
- Lung Cancer
- Being tested
- Microwave ablation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave ablationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| CT_ guided percutaneous microwave ablation | Experimental | The procedure will be done under anaesthesia by interventional radiologist Receives: Procedure: Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving adequacy of ablation
Defined as perilesional circumferential solid area of ground glass opacification of >4mm
Measured: 24 hours post ablation
Percentage of patients achieving technical efficacy
Defined as lack of enhancement within the ablated zone
Measured: 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.
Measured: From the date of ablation up to six months
Secondary outcomes (1)
Adverse events
Defined as incidence of intra , peri and post procedural complications
Measured: From the date of ablation up to six months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start15 Jul 2020 (estimated)
- Primary completion13 May 2022 (estimated)
- Study completion12 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham M Farghally, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081181
- Sponsor's protocol ID
- MWAL
- Status last verified
- Jun 2020
- First submitted
- 5 Sep 2019
- Last updated
- 25 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25220842Jahangeer 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.
PubMed 23601905Weiser 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.
PubMed 10945362Smith 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.
PubMed 18294807Zhong 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.
PubMed 28449467Bonichon 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.
PubMed 26384598Shahzad 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.
PubMed 25616160Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.
PubMed 16227498Carrafiello 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.
PubMed 19186116Cheng 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.
PubMed 26892261Pacella 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.
PubMed 23391859Anderson 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.
PubMed 19127381Chheang 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.
PubMed 24436532
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT_ Guided Percutaneous Microwave Ablation in Treatment of Pulmonary Malignancies
- ClinicalTrials.gov ID
- NCT04081181
- Acronym / sponsor ID
- MWAL
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 13 May 2022 (estimated)
- Study completion
- 12 Aug 2022 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT_ guided percutaneous microwave ablation | Experimental | Procedure: Microwave ablationThe procedure will be done under anaesthesia by interventional radiologist |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patient has good compliance and sign the informed consent.
Key exclusion criteria (4 listed)
- patient is pregnant or breast feeding .
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 |
|---|---|---|
| Microwave ablationCT_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 | Procedure or surgery | CT_ guided percutaneous microwave ablation |
Primary outcome
Percentage of patients achieving adequacy of ablation
Time frame: 24 hours post ablation
Defined as perilesional circumferential solid area of ground glass opacification of >4mm
Percentage of patients achieving technical efficacy
Time frame: 1 month after ablation
Defined as lack of enhancement within the ablated zone
Local progression free survival
Time frame: From the date of ablation up to six months
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.
1 secondary outcome
Adverse events
Time frame: From the date of ablation up to six months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 23601905Jahangeer 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.
- Background: PubMed 10945362Weiser 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.
- Background: PubMed 18294807Smith 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.
- Background: PubMed 28449467Zhong 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.
- Background: PubMed 26384598Bonichon 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.
- Background: PubMed 25616160Shahzad 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.
- Background: PubMed 16227498Simon CJ, Dupuy DE, Mayo-Smith WW. Microwave ablation: principles and applications. Radiographics. 2005 Oct;25 Suppl 1:S69-83. doi: 10.1148/rg.25si055501.
- Background: PubMed 19186116Carrafiello 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.
- Background: PubMed 26892261Cheng 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.
- Background: PubMed 23391859Pacella 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.
- Background: PubMed 19127381Anderson 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave ablation in people with Lung Cancer, run by Assiut University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Ahmed Mamdouh El_Sharkawy, Prof.Dr (01223971443, Drmostafamri@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving adequacy of ablation (time frame: 24 hours post ablation). The study lists 3 primary outcomes in all. 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 NCT04081181, which also lists 13 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 25 Jun 2020; AzTrials last refreshed its copy on 30 Oct 2026.