CT versus MR guidance for radiofrequency ablation in patients with colorectal liver metastases: a 10-year follow-up favors MR guidance.

OBJECTIVES: To compare the results of CT- vs MR-guided radiofrequency ablation (RFA) of liver metastases (LM) from colorectal cancer after 10 years of follow-up in an observational, retrospective, and multicentric study. METHODS: A total of 238 patients with 496 LM were treated with RFA either with CT (CT group) or magnetic resonance (MR group) guidance. Every ablated LM was assessed and followed up with diagnostic MRI. Technical success, technique efficacy, predictive factors, recurrence rates, and overall survival were assessed. RESULTS: The CT group comprised 143 patients and the MR group 77 patients. Eighteen patients underwent ablation with both modalities. Technical success per patient and per lesion was 88% and 93% for CT and 87% and 89.6% for MR, and technique efficacy was 97.1% and 98.6% for CT and 98.7% and 99.3% for MR respectively. Local recurrence following the first ablation (primary patency) occurred in 20.1% (CT) vs 4.6% (MR) (p < 0.001). Residual liver tumor, size of LM, and advanced N and M stage at initial diagnosis were independent predictors for overall survival in both groups. The median overall survival measured from first RFA treatment was 2.6 years. The 1-year, 5-year, and 10-year survival were 85.9%, 25.5%, and 19.1% respectively. CONCLUSIONS: The MR group had significantly better local control compared to the CT group. There was no significant difference in patient survival between the two groups. CLINICAL RELEVANCE STATEMENT: MR-guided radiofrequency ablation of colorectal liver metastases is safe and effective, and offers better local control than CT-guided ablation. KEY POINTS: • Imaging modality for radiofrequency ablation guidance is an independent predictor of local recurrence in colorectal liver metastases. • MR-guided radiofrequency ablation achieved better local control of liver metastases from colorectal cancer than CT-guided. • The number and size of liver metastases are, among others, independent predictors of survival. Radiofrequency ablation with MR guidance improved clinical outcome but does not affect survival.

[Transarterial radioembolization of hepatocellular carcinoma and intrahepatic cholangiocarcinoma]. / Transarterielle Radioembolisation des hepatozellulären Karzinoms und des intrahepatischen Cholangiokarzinoms.

Since the first version of the S3 guideline for the diagnosis and treatment of hepatocellular carcinoma (HCC) in 2013, a large number of studies have consolidated the data on transarterial radioembolization (TARE) and created a broad evidence base. As a result, TARE was incorporated into the current 2021 S3 guideline with a number of specific recommendations, whereas it was previously only offered under study conditions. TARE is now offered with the other minimally invasive procedures for bridging and downstaging before liver transplantation, but also as an alternative to transarterial chemotherapy (TACE) in intermediate HCC and in locally limited intrahepatic cholangiocarcinoma in second-line therapy for selected patients-albeit with different levels of evidence. Based on the study situation, however, TARE is not recommended for advanced HCC; here, systemic therapy with immunotherapeutic agents is preferred based on current data.

[International comparison of radiological aspects of the new German S3 guideline on hepatocellular carcinoma and intrahepatic cholangiocarcinoma]. / Radiologische Aspekte der neuen deutschen S3-Leitlinie zum hepatozellulären Karzinom und biliären Karzinomen im internationalen Vergleich.

The updated German S3 guideline "Diagnostics and therapy of hepatocellular carcinoma and biliary carcinomas" covers two tumor entities. The original guideline published in 2013 focusing only on the diagnosis and therapy of hepatocellular carcinoma (HCC) has been expanded to include intrahepatic cholangiocarcinoma. These guidelines were developed within the framework of the guideline program on oncology of the Scientific Medical Society e. V. (AWMF), the German Cancer Society (DKG) and German Cancer Aid Society (DKG) under the auspices of the German Society for Digestive and Metabolic Diseases (DGVS). In addition to updated recommendations regarding histopathology, radiological diagnostics and treatments, the main innovations of the revised guidelines on HCC include a complete revision of the section on the systemic therapeutic approach in advanced stages of the disease. This article presents the significance of the current recommendations for diagnostic and interventional radiology in comparison to other national and international guidelines and should serve to improve the quality of patient care through more widespread dissemination.

Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative.

There is currently no consensus regarding preferred clinical outcome measures following image-guided tumor ablation or clear definitions of oncologic end points. This consensus document proposes standardized definitions for a broad range of oncologic outcome measures with recommendations on how to uniformly document, analyze, and report outcomes. The initiative was coordinated by the Society of Interventional Oncology in collaboration with the Definition for the Assessment of Time-to-Event End Points in Cancer Trials, or DATECAN, group. According to predefined criteria, based on experience with clinical trials, an international panel of 62 experts convened. Recommendations were developed using the validated three-step modified Delphi consensus method. Consensus was reached on when to assess outcomes per patient, per session, or per tumor; on starting and ending time and survival time definitions; and on time-to-event end points. Although no consensus was reached on the preferred classification system to report complications, quality of life, and health economics issues, the panel did agree on using the most recent version of a validated patient-reported outcome questionnaire. This article provides a framework of key opinion leader recommendations with the intent to facilitate a clear interpretation of results and standardize worldwide communication. Widespread adoption will improve reproducibility, allow for accurate comparisons, and avoid misinterpretations in the field of interventional oncology research. Published under a CC BY 4.0 license. Online supplemental material is available for this article. See also the editorial by Liddell in this issue.

LifePearl microspheres loaded with irinotecan in the treatment of Liver-dominant metastatic colorectal carcinoma: feasibility, safety and pharmacokinetic study.

To evaluate pharmacokinetic and safety profile of LifePearl microspheres loaded with irinotecan (LifePearl-IRI) in the treatment of liver-dominant, metastatic colorectal carcinoma (LM-CRC) by transarterial chemoembolization. In a prospective, multicentre pharmacokinetic study, 14 patients with LM-CRC progressing on at least one line of chemotherapy were treated with LifePearl-IRI. Six patients received unilobar treatment, treating one lobe per session with 100 mg of irinotecan every 2 weeks. Eight patients received bilobar treatment, treating two lobes per session with 100 mg of irinotecan each (200 mg in total), every 4 weeks. At 24 h, near complete plasma clearance occurred for both irinotecan and SN-38, regardless of the dose. Mean plasma Cmax(100 mg) was 254.50 ± 104.17 ng/mL for irinotecan and 46.72 ± 13.75 ng/mL for SN-38. Mean Cmax(200 mg) was 970.09 ± 353.75 ng/mL for irinotecan and 118.45 ± 25.11 ng/mL for SN-38. Significantly higher Cmax-iri(200 mg) than Cmax-iri (100 mg) supported rate-limiting irinotecan-to-SN-38 conversion. Adverse events during the first 30 days upon initial treatment were hypertension in 21.4%, abdominal pain in 14.3%, and increased transaminases and fever in 7.1% of patients. Four serious adverse events were noted: respiratory failure, constipation, necrotizing pancreatitis, and ischaemic cholecystitis. Chemoembolization with LifePearl-IRI is technically feasible and relatively well tolerated, with a good pharmacokinetic profile and minimal systemic exposure of both irinotecan and SN-38, after both unilobar and bilobar treatment with 100 or 200 mg, respectively.

Intra-arterial Injection of Lidocaine as a Cell Sensitizer during Irreversible Electroporation.

PURPOSE: To investigate whether intra-arterial injection of lidocaine enhances irreversible electroporation (IRE) in a liver model. MATERIALS AND METHODS: Conventional IRE (C-IRE) and lidocaine-enhanced IRE (L-IRE) were performed in 8 pig livers. Protocol 1 (tip exposure and electrode distance of 2.0 cm each) and protocol 2 (increased tip exposure and electrode distance 2.5 cm each) were used. Animals were sacrificed 3 hours after IRE. Study goals included electrical tissue properties (eg, current, conductivity) during IRE, geometry of IRE zones analyzed using computed tomography and magnetic resonance imaging (eg, volume and sphericity index), degree of acute liver damage, and irreversible cell death analyzed using microscopy (hematoxylin and eosin staining and terminal deoxynucleotidyl transferase deoxyuridine 5-triphosphate nick end labeling). Statistical comparisons were performed using the paired t test and Wilcoxon test. RESULTS: All treatments were performed without adverse events. Electrical tissue properties were not significantly different between C-IRE and L-IRE. For protocol 1, the diameter of the largest sphere within the IRE zone was significantly larger for L-IRE than for C-IRE (25.0 ± 4.7 mm vs 18.4 ± 3.1 mm [P = .013]). For protocol 2, the volume of IRE zone was significantly larger for L-IRE compared with C-IRE (46.0 ± 5.4 cm3 vs 22.6 ± 6.4 cm3 [P = .018]), as well as the diameter of the largest sphere within the IRE zone (27.1 ± 2.2 mm vs 19.8 ± 2.3 mm [P = .020]). For protocol 1, a significantly higher degree of irreversible cell death was noted for L-IRE than for C-IRE (1.8 ± 1.0 vs 0.8 ± 1.0 [P = .046]). CONCLUSIONS: Intra-arterial injection of lidocaine can enhance IRE in terms of larger IRE zones and an increase of irreversible cell death.

Feasibility, efficacy, and safety of percutaneous MR-guided ablation of small (≤12 mm) hepatic malignancies.

BACKGROUND: Percutaneous tumor ablation is commonly performed using computed tomography (CT) or ultrasound (US) guidance, although reliable visualization of the target tumor may be challenging. MRI guidance provides more reliable visualization of target tumors and allows for real-time imaging and multiplanar capabilities, making it the modality of choice, in particular if lesions are small. PURPOSE: To investigate the feasibility, technical success, and safety of percutaneous MR-guided ablation (RFA n = 27 / MWA n = 16) of small (≤12 mm) hepatic malignancies. STUDY TYPE: Retrospective case study. POPULATION: In all, 45 patients (age: 61.1 ± 11.8) with hepatic malignancies and a lesion diameter of ≤12 mm scheduled for percutaneous MR-guided tumor ablation based on a tumor board decision were included. FIELD STRENGTH: A 1.5T MR system was used for planning, targeting, and monitoring. ASSESSMENT: Feasibility assessment included the detection of the target tumor, tumor delineation during MR-fluoroscopy guided targeting, and the number of attempts needed for precise applicator placement. Technical success was defined as successful performance of the procedure including a safety margin of 5 mm. Safety evaluation was based on procedure-related complications. STATISTICAL TEST: Frequency. RESULTS: Tumor ablation (mean diameter 9.0 ± 2.1 mm) was successfully completed in 43/45 patients. Planning imaging was conducted without a contrast agent in 79% (n = 37). In 64% (n = 30), the target tumors were visible with MR-fluoroscopy. In six patients (13%), planning imaging revealed new, unexpected small lesions, which were either treated in the same session (n = 4) or changed therapy management (n = 2) due to diffuse tumor progress. Postprocedural imaging revealed a technical success of 100% (43/43), with no major complications. During follow-up, no local tumor progression was observed (mean follow-up 24.7 ± 14.0 months) although 28% (12) patients developed new hepatic lesions distant to the ablation zone. No major complications were observed. DATA CONCLUSION: MR-guided ablation is a feasible approach for an effective and safe treatment of small hepatic malignancies. LEVEL OF EVIDENCE: 4 Technical Efficacy: Stage 4 J. Magn. Reson. Imaging 2019;49:374-381.

The value of iterative metal artifact reduction algorithms during antenna positioning for CT-guided microwave ablation.

Objectives: To compare image quality between filtered back projection (FBP) and iterative reconstruction algorithm and dedicated metal artifact reduction (iMAR) algorithms during antenna positioning for computed tomography-guided microwave ablation (MWA).Materials and methods: An MWA antenna was positioned in the liver of five pigs under CT guidance. Different exposure settings (120kVp/200mAs-120kVp/50mAs) and image reconstruction techniques (FBP, iterative reconstruction with and without iMAR) were applied. Quantitative image analysis included density measurements in six positions (e.g., liver in extension of the antenna [ANTENNA] and liver >3 cm away from the antenna [LIVER-1]). Qualitative image analysis included assessment of overall quality, image noise, artifacts at the antenna tip, artifacts in liver parenchyma bordering antenna tip and newly generated artifacts. Two independent observers performed the analyses twice and interreader agreement was compared with Bland-Altman analysis.Results: For all exposure and reconstruction settings, density measurements for ANTENNA were significantly higher for the I30-1 iMAR compared with FBP and I30-1 (e.g., 8.3-17.2HU vs. -104.5 to 155.1HU; p ≤ 0.01, respectively). In contrast, for all exposure settings, density measurements for LIVER-1 were comparable between FBP and I30-1 iMAR (e.g., 49.4-50.4HU vs. 50.1-52.5U, respectively). For all exposure and reconstruction settings, subjective image quality for LIVER-1 was better for the I30-1 iMAR algorithm compared with FBP and I30-1. Bland-Altman interobserver agreement was from -0.2 to 0.2 for FBP and iMAR, and Cohen's kappa was 0.74.Conclusion: Iterative algorithms I30-1 with iMAR algorithm improves image quality during antenna positioning and placement for CT-guided MWA and is applicable over a range of exposure settings.

Intraprocedural 3D perfusion measurement during chemoembolisation with doxorubicin-eluting beads in liver metastases of malignant melanoma.

OBJECTIVES: To study feasibility and validity of a new software application for intraprocedural assessment of perfusion during chemoembolisation of melanoma metastases. METHODOLOGY: In a prospective phase-II trial, ten melanoma patients with liver-only metastases underwent chemoembolisation with doxorubicin-eluting beads (DEBDOX-TACE). Tumour perfusion was evaluated immediately before and after treatment at cone beam computer tomography (CBCT) using a new software application. For control and comparison, patients underwent perfusion measurement via contrast-enhanced multidetector CT (MDCT) before and after treatment. RESULTS: CBCT showed 94.7 % reduction in perfusion in metastases after DEBDOX-TACE, whereas MDCT showed 96.8 %. Reduction in perfusion after treatment was statistically significant (p < 0.01) for both methods. The additional time needed for data acquisition during treatment was 5 min per case or less; the post-processing data analysis was 10 min or less. Perfusion imaging was associated with additional contrast agent and patient exposure to radiation (dose-length product [DLP]): 18 ml and 394 mGy*cm in CBCT and 100 ml and 446 mGy*cm in MDCT, respectively. CONCLUSIONS: Reduction in perfusion of melanoma metastases after DEBDOX-TACE can be reliably assessed during the intervention via perfusion software at CBCT. Data acquisition and analysis require additional time but can be easily performed during the treatment. KEY POINTS: • Tumour perfusion of melanoma metastases can be assessed at cone beam CT. • The software shows a significant decrease of tumour perfusion after DEBDOX-TACE. • Data acquisition and analysis require an acceptable additional time during the procedure. • CBCT requires less radiation exposure and contrast for perfusion study than MSCT. • This software can monitor the course of DEBDOX-TACE in melanoma metastases.

In vitro artifact assessment of an MR-compatible, microwave antenna device for percutaneous tumor ablation with fluoroscopic MRI-sequences.

OBJECTIVE: To evaluate artifact configuration and diameters of a magnetic resonance (MR) compatible microwave (MW) applicator using near-realtime MR-fluoroscopic sequences for percutaneous tumor ablation procedures. MATERIAL AND METHODS: Two MW applicators (14 G and 16 G) were tested in an ex-vivo phantom at 1.5 T with two 3 D fluoroscopic sequences: T1-weighted spoiled Gradient Echo (GRE) and T1/T2-weighted Steady State Free Precession (SSFP) sequence. Applicator orientation to main magnetic field (B0), slice orientation and phase encoding direction (PED) were systematically varied. The influence of these variables was assessed with ANOVA and post-hoc testing. RESULTS: The artifact was homogenous along the whole length of both antennas with all tested parameters. The tip artifact diameter of the 16 G antenna measured 6.9 ± 1.0 mm, the shaft artifact diameter 8.6 ± 1.2 mm and the Tip Location Error (TLE) was 1.5 ± 1.2 mm.The tip artifact diameter of the 14 G antenna measured 7.7 ± 1.2 mm, the shaft artifact diameter 9.6 ± 1.5 mm and TLE was 1.6 ± 1.2 mm. Orientation to B0 had no statistically significant influence on tip artifact diameters (16 G: p = .55; 14 G: p = .07) or TLE (16 G: p = .93; 14 G: p = .26). GRE sequences slightly overestimated the antenna length with TLE(16 G) = 2.6 ± 0.5 mm and TLE(14 G) = 2.7 ± 0.7 mm. CONCLUSIONS: The MR-compatible MW applicator's artifact seems adequate with an acceptable TLE for safe applicator positioning during near-realtime fluoroscopic MR-guidance.

MR-guided microwave ablation in hepatic tumours: initial results in clinical routine.

OBJECTIVES: Evaluation of the technical success, patient safety and technical effectiveness of magnetic resonance (MR)-guided microwave ablation of hepatic malignancies. METHODS: Institutional review board approval and informed patient consent were obtained. Fifteen patients (59.8 years ± 9.5) with 18 hepatic malignancies (7 hepatocellular carcinomas, 11 metastases) underwent MR-guided microwave ablation using a 1.5-T MR system. Mean tumour size was 15.4 mm ± 7.7 (7-37 mm). Technical success and ablation zone diameters were assessed by post-ablative MR imaging. Technique effectiveness was assessed after 1 month. Complications were classified according to the Common Terminology Criteria for Adverse Events (CTCAE). Mean follow-up was 5.8 months ± 2.6 (1-10 months). RESULTS: Technical success and technique effectiveness were achieved in all lesions. Lesions were treated using 2.5 ± 1.2 applicator positions. Mean energy and ablation duration per tumour were 37.6 kJ ± 21.7 (9-87 kJ) and 24.7 min ± 11.1 (7-49 min), respectively. Coagulation zone short- and long-axis diameters were 31.5 mm ± 10.5 (16-65 mm) and 52.7 mm ± 15.4 (27-94 mm), respectively. Two CTCAE-2-complications occurred (pneumothorax, pleural effusion). Seven patients developed new tumour manifestations in the untreated liver. Local tumour progression was not observed. CONCLUSIONS: Microwave ablation is feasible under near real-time MR guidance and provides effective treatment of hepatic malignancies in one session. KEY POINTS: • Planning, applicator placement and therapy monitoring are possible without using contrast enhancement • Energy transmission from the generator to the scanner room is safely possible • MR-guided microwave ablation provides effective treatment of hepatic malignancies in one session • Therapy monitoring is possible without applicator retraction from the ablation site.

Preclinical evaluation of an MR-compatible microwave ablation system and comparison with a standard microwave ablation system in an ex vivo bovine liver model.

OBJECTIVE: Evaluation of a newly developed MR-compatible microwave ablation system with focus on ablation performance and comparison with a corresponding standard microwave ablation system. MATERIALS AND METHODS: A total of 52 ablations were performed with a non-cooled microwave ablation system in an ex vivo bovine liver model using the following settings: [A] 16G-standard antenna, 2 cm active tip, 2.4 m cable; [B] MR-compatible 16G-antenna, 2 cm active tip, 2.4 m cable; [C] MR-compatible 16G-antenna, 2 cm active tip, extended 6 m cable; and [D] MR-compatible 16G-antenna, 4 cm active tip, extended 6 m cable. Ablation durations were 3, 5 and 10 min, and additionally 15 min for [D]. Ablations zones were measured for short-axis diameter (SA) and long-axis diameter (LA). Settings [A]-[C] were compared regarding SA, volume (V) and generator energy output (E) with analysis of variance and Tukey-Kramer post hoc test. Ablation performance of the MR-compatible settings [C] and [D] were compared regarding SA, V, E and sphericity index (SA/LA) with unpaired t-test. p < 0.05 was considered as statistically significant. RESULTS: No significant differences were found between [A], [B] and [C] regarding SA and V (10 min; SA[A] = 25.8 ± 2.4 mm, SA[B] = 25.3 ± 1.9 mm, SA[C] = 25.0 ± 2.0 mm, p = 0.88; V[A] = 17.8 ± 4.4 cm³, V[B] = 16.6 ± 3.0 cm³, V[C] = 17.8 ± 2.7 cm³, p = 0.85); however, the highest energy output was measured for setting [C] (10 min; [A]: 9.9 ± 0.5 kJ, [B]: 10.1 ± 0.5 kJ, [C]: 13.1 ± 0.3 kJ, p < 0.001). SA, V and E were significantly larger with setting [D] than [C] with 10 min ablations (SA[C] = 25.0 ± 2.0 mm, SA[D] = 34.0 ± 2.9 mm, p = 0.003; V[C] = 17.8 ± 2.7 cm³, V[D] = 39.4 ± 7.5 cm³, p = 0.007; E[C] = 13.1 ± 0.3 kJ, E[D] = 16.7 ± 0.8 kJ, p = 0.002) without significant difference in sphericity index (SA/LA[C] = 0.46 ± 0.02, SA/LA[D] = 0.52 ± 0.04, p = 0.08). CONCLUSION: The tested MR-compatible system can be used without loss of ablation performance compared to the standard system.

Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy.

BACKGROUND The aim of this study was to evaluate the safety and efficacy of DSM (degradable starch microspheres) as an embolic agent in transarterial chemoembolization in the treatment of intrahepatic cholangiocellular carcinoma (ICC). MATERIAL AND METHODS This was a national, multi-center observational cohort study on the safety and efficacy of DSM-TACE using mitomycin, gemcitabine, cisplatin, doxorubicin, and carboplatin in palliative treatment of ICC. Recruitment period for the study was from January 2010 to June 2014. Primary endpoints were toxicity, safety, and response according to mRECIST criteria. RESULTS Twenty-five DSM-TACE procedures in cases of advanced ICC were performed in seven patients. Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87.5%) associated with the use of gemcitabine. In 11 out of 25 treatments (44%) moderate, transient epigastric pain was registered as an adverse event (AE) within 24 hours of DSM-TACE. One case (1/25) of severe AE (4%) with thrombocytopenia led to discontinuation of the DSM-TACE-treatment. A total of 25 DSM-TACE procedures with complete clinical and imaging follow-up over a two-year-period were analyzed: objective response (OR) was achieved in three of 25 treatments (12%) Disease control (DC) was achieved in 44% (11/25) of treatments; progress was registered in 4% (1/25). CONCLUSIONS The use of DSM as an embolic agent for TACE is safe in the treatment of ICC. A standardized anti-emetic medication should be established, especially when using gemcitabine. Further prospective studies need to be conducted to find the most suitable, standardized DSM-TACE treatment regime.