Colorectal liver metastatic disease: efficacy of irreversible electroporation--a single-arm phase II clinical trial (COLDFIRE-2 trial).
BACKGROUND
Irreversible electroporation (IRE) is a novel image-guided tumor ablation technique that has shown promise for the ablation of lesions in proximity to vital structures such as blood vessels and bile ducts. The primary aim of the COLDFIRE-2 trial is to investigate the efficacy of IRE for unresectable, centrally located colorectal liver metastases (CRLM). Secondary outcomes are safety, technical success, and the accuracy of contrast-enhanced (ce)CT and (18)F-FDG PET-CT in the detection of local tumor progression (LTP).


METHODS
In this single-arm, multicenter phase II clinical trial, twenty-nine patients with (18)F-FDG PET-avid CRLM ≤ 3,5 cm will be prospectively included to undergo IRE of the respective lesion. All lesions must be unresectable and unsuitable for thermal ablation due to vicinity of vital structures. Technical success is based on ceMRI one day post-IRE. All complications related to the IRE procedure are registered. Follow-up consists of (18)F-FDG PET-CT and 4-phase liver CT at 3-monthly intervals during the first year of follow-up. Treatment efficacy is defined as the percentage of tumors successfully eradicated 12 months after the initial IRE procedure based on clinical follow-up using both imaging modalities, tumor marker and (if available) histopathology. To determine the accuracy of (18)F-FDG PET-CT and ceCT, both imaging modalities will be individually scored by two reviewers that are blinded for the final oncologic outcome.


CONCLUSIONS
To date, patients with a central CRLM unsuitable for resection or thermal ablation have no curative treatment option and are given palliative chemotherapy. For these patients, IRE may prove a life-saving treatment option. The results of the proposed trial may represent an important step towards the implementation of IRE for central liver tumors in the clinical setting.


BACKGROUND



BACKGROUND
NCT02082782.
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. hj.scheffer@vumc.nl.
Hester J
HJ
Scheffer
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. la.vroomen@vumc.nl.
Laurien G P H
LG
Vroomen
Department of Surgery, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. k.nielsen@vumc.nl.
Karin
K
Nielsen
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. a.vantilborg@vumc.nl.
Aukje A J M
AA
van Tilborg
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. efi.comans@vumc.nl.
Emile F I
EF
Comans
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. c.vankuijk@vumc.nl.
Cornelis
C
van Kuijk
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. b.vandermeijs@vumc.nl.
Bram B
BB
van der Meijs
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. j.vandenbergh@vumc.nl.
Janneke
J
van den Bergh
Department of Surgery, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. mp.vandentol@vumc.nl.
Petrousjka M P
PM
van den Tol
Department of Radiology and Nuclear Medicine, VU University Medical Center, de Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. mr.meijerink@vumc.nl.
Martijn R
MR
Meijerink
D055011:Ablation Techniques / Q000379:methods*; D000368:Aged; D015179:Colorectal Neoplasms / Q000473:pathology*; D018274:Electroporation; D005260:Female; D019788:Fluorodeoxyglucose F18; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed / Q000379:methods
D019788:Fluorodeoxyglucose F18