Colorectal liver metastatic disease: efficacy of irreversible electroporation—a single-arm phase II clinical trial (COLDFIRE-2 trial). Issue 1 (December 2015)

• Record Type: Journal Article
• Authors: Scheffer, Hester; Vroomen, Laurien; Nielsen, Karin; van Tilborg, Aukje; Comans, Emile; van Kuijk, Cornelis; van der Meijs, Bram; van den Bergh, Janneke; van den Tol, Petrousjka; Meijerink, Martijn
• Is Part Of: BMC cancer. Volume 15:Issue 1(2015)
• Page Start: 1
• Page End: 7
• Publication Date: 2015-12
• Subjects: Irreversible electroporation (IRE) -- Liver neoplasms/secondary -- Local -- FDG-PET -- PET-CT -- Tumor ablation -- Neoplasm recurrence -- Colorectal liver metastases; Cancer -- Periodicals; 616.994005
• DOI: 10.1186/s12885-015-1736-5
• Languages: English
• ISSNs: 1471-2407

Abstract

Abstract 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 and18 F-FDG PET-CT in the detection of local tumor progression (LTP). Methods/design In this single-arm, multicenter phase II clinical trial, twenty-nine patients with18 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 of18 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 of18 F-FDG PET-CT and ceCT, both imaging modalities will be individually scored by two reviewers that are blinded for the final oncologic outcome. Discussion 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. Trial registration Trial registration number:NCT02082782 .