Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases (COLDFIRE-2)
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|ClinicalTrials.gov Identifier: NCT02082782|
Recruitment Status : Unknown
Verified April 2016 by Dr. M.R. Meijerink, Amsterdam UMC, location VUmc.
Recruitment status was: Recruiting
First Posted : March 10, 2014
Last Update Posted : April 29, 2016
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeastasis.
The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for resection or thermal ablation due to vicinity to vulnerable structures such as vessels and bile ducts. Other objectives are safety, feasibility (technical success) and imaging characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities in dianosing local site recurrence (LSR) or residual disease (RD).
29 patients with histologically confirmed colorectal carcinoma who present with unresectable and not thermally ablative CRLM< 3.5cm suitable for IRE will undergo percutaneous or open irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious) adverse events are registered. One day post-IRE MRI is performed to assess technical success. Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize residual or recurrent disease. Overall technique effectiveness is determined 1 year after treatment.
The investigators hypothesize that IRE for central CRLM will lead to good tumor control without causing severe complications.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Liver Metastases||Procedure: Irreversible electroporation (IRE)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Colorectal Metastatic Liver Disease: Efficacy of Irreversible Electroporation (IRE) - a Phase II Clinical Trial (COLDFIRE-2 Study)|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2018|
Experimental: irreversible electroporation (IRE)
Single arm study: percutaneous or open irreversible electropration of CRLM
Procedure: Irreversible electroporation (IRE)
Percutaneous (CT-guided) or open (US-guided) irreversible electroporation of central colorectal liver metastasis.
Other Name: NanoKnife
- Efficacy [ Time Frame: 12 months ]The primary objective of this project is to evaluate the efficacy (percentage of lesions that show no sign of recurrence 12 months after the initail IRE procedure) of IRE for CRLM on cross-sectional imaging performed after respectively 6 weeks, and after 3, 6, 9 and 12 months. Research has shown that 95% of all recurrences after RFA of CRLM are diagnosed within one year after treatment. Therefore, one year follow-up will allow for accurate calculation of efficacy. Exact secondary efficacy rate may require follow-up longer than 12 months since this includes lesions that have been re-treated due to local site recurrence/local tumor residue (which will be individualized for each patient after re-treatment of LSR/LTR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082782
|Contact: Hester J Scheffer, MDfirstname.lastname@example.org|
|Contact: Martijn R Meijerink, MD, PhDemail@example.com|
|VU University Medical Center||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1081 HV|
|Contact: Hester J Scheffer, MD +31204444533 firstname.lastname@example.org|
|Contact: Martijn R Meijerink, MD, PhD +314444444 email@example.com|
|Academic Medical Center||Recruiting|
|Amsterdam, Noord-Holland, Netherlands, 1105 AZ|
|Contact: Jantien A Vogel, MD +31205669111 firstname.lastname@example.org|
|Contact: Krijn P van Lienden, MD, PhD +31205669111 email@example.com|
|Leiden University Medical Center||Recruiting|
|Leiden, Zuid-Holland, Netherlands, 2333 ZA|
|Contact: Arian R van Erkel, MD, PhD +3171 526 9111 firstname.lastname@example.org|
|Principal Investigator:||Martijn R Meijerink, MD, PhD||VU University Medical Center (VUmc)|
|Principal Investigator:||Krijn P van Lienden, MD, PhD||Academic Medical Center Amsterdam (AMC)|
|Principal Investigator:||Arian R van Erkel, MD, PhD||Leiden University Medical Center (LUMC)|