Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Oncology Clinical Trial

Official title:

Irreversible Electroporation for Treatment of Solid Abdominal Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03169439
• Other study ID #: IREAT
• Status: Not yet recruiting
• Phase: N/A
• First received: May 25, 2017
• Last updated: May 26, 2017
• Start date: July 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Hosam Abozaid Yousef, MD
• Phone: 00201063602906
• Email: hosameldeen68[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Irreversible electroporation (IRE) is a novel non-thermal ablation modality with promise for revolutionizing the treatment for local solid tumors.

With the growing demand for alternative and less invasive treatments for localized tumors, the investigators have seen the development and investigation of several tissue ablation modalities, including radiofrequency ablation (RFA), microwave ablation, and cryoablation. Although these modalities have been efficacious, they have some disadvantages owing to their reliance on thermal energy for creating cell death.

Description:

Irreversible electroporation is novel in that it does not use thermal energy, but electrical energy to produce focused cell death while sparing the normal extracellular matrix, nearby vessels, and structures, while allowing for rapid normal tissue regrowth.

Unlike thermal ablation modalities, Irreversible electroporation does not require significant consideration for dissipation of thermal energy, or heat sink, and has less complications relating to damage of normal soft tissue, eliminating a major cause of treatment failure.

Irreversible electroporation is a novel minimally invasive tumor/tissue ablation technique that can be used under guidance of ultrasound (US) or computed tomography (CT), without inducing thermal damaging effects, and with preservation of the surrounding vital structures such as vessels, bile ducts, urethra, and nerves which remain intact to function normally, even in locally advanced tumors. The technique depends upon inducing apoptotic non-necrotic cell death in short procedure time.

It has the advantage of allowing quick tissue regeneration. Irreversible electroporation treatment time is significantly shorter than traditional thermal ablation modalities, usually in few minutes range, and allows for treating considerably larger lesions than thermal ablation modalities.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: August 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with unresectable solid abdominal tumors (hepatic, pancreatic, porta hepatis,…).

• The mass measures less than 4 cm.

• Associated with no or oligo metastatic lesions

Exclusion Criteria:

• Patients with cardiac arrhythmia and pacemaker.

• Patients unfit for general anesthesia.

• The lesion size is larger than 4 cm.

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Oncology

Intervention

Procedure:
• Irreversible electroporation
minimal invasive ablative technique for tumors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Davalos RV, Mir IL, Rubinsky B. Tissue ablation with irreversible electroporation. Ann Biomed Eng. 2005 Feb;33(2):223-31. — View Citation

Edd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B. In vivo results of a new focal tissue ablation technique: irreversible electroporation. IEEE Trans Biomed Eng. 2006 Jul;53(7):1409-15. — View Citation

Esser AT, Smith KC, Gowrishankar TR, Weaver JC. Towards solid tumor treatment by nanosecond pulsed electric fields. Technol Cancer Res Treat. 2009 Aug;8(4):289-306. — View Citation

Kasivisvanathan V, Thapar A, Oskrochi Y, Picard J, Leen EL. Irreversible electroporation for focal ablation at the porta hepatis. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1531-4. doi: 10.1007/s00270-012-0363-7. Epub 2012 Feb 25. — View Citation

Lee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST. Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology. 2010 May;255(2):426-33. doi: 10.1148/radiol.10090337. — View Citation

Rubinsky B. Irreversible electroporation in medicine. Technol Cancer Res Treat. 2007 Aug;6(4):255-60. — View Citation

Silk MT, Wimmer T, Lee KS, Srimathveeravalli G, Brown KT, Kingham PT, Fong Y, Durack JC, Sofocleous CT, Solomon SB. Percutaneous ablation of peribiliary tumors with irreversible electroporation. J Vasc Interv Radiol. 2014 Jan;25(1):112-8. doi: 10.1016/j.jvir.2013.10.012. Epub 2013 Nov 18. — View Citation

Usman M, Moore W, Talati R, Watkins K, Bilfinger TV. Irreversible electroporation of lung neoplasm: a case series. Med Sci Monit. 2012 Jun;18(6):CS43-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ablation success	the ability to deliver planned therapy and to have no residual	3 months
Secondary	Local recurrence	defined as re appearance of viable tumor after period during which no tumor could be detected	3,6 and 12 months