Local Tumour Control Following Microwave Ablation: Protocol for the Prospective Observational CIEMAR Study.

PURPOSE: Microwave ablation (MWA) is a treatment modality for colorectal liver metastases (CRLM). While potentially curative, more information is needed on factors that contribute to long-term local tumour control. The prospective multicentre observational study CIRSE Emprint Microwave Ablation Registry aims to prospectively collect real-world technical data and clinical outcomes on patients treated with MWA in CRLM. METHODS: Eligible patients are adults with up to 9 local treatment naïve CRLM of ≤ 3 cm completely treatable with either MWA alone or MWA with resection and/or radiotherapy within 8 weeks. Data are collected, at baseline, every 3 months until 12 months, and thereafter every 6 months until the end of the study. The primary outcome measure is local tumour control. Secondary outcome measures are overall survival, (hepatic-) disease-free survival, time-to-progression untreatable by ablation, systemic therapy vacation, safety, and quality of life. Covariates related to the primary outcome measure will be assessed using a stratified log-rank test and an univariable Cox proportional hazard regression. A sample size of 500 patients with 750 lesions produces a two-sided 95% confidence interval with a precision equal to 0.057. RESULTS: Between September 2019 and December 2022, 500 patients have been enrolled with at least 976 treated tumours. CONCLUSION: The prospective observational CIEMAR study will provide valuable insights into the real-world use of MWA, helping in the future patient selection and clarifying factors that may contribute to long-term local tumour control. TRIAL REGISTRATION: NCT03775980.

CIRSE Position Paper on Artificial Intelligence in Interventional Radiology.

Artificial intelligence (AI) has made tremendous advances in recent years and will presumably have a major impact in health care. These advancements are expected to affect different aspects of clinical medicine and lead to improvement of delivered care but also optimization of available resources. As a modern specialty that extensively relies on imaging, interventional radiology (IR) is primed to be on the forefront of this development. This is especially relevant since IR is a highly advanced specialty that heavily relies on technology and thus is naturally susceptible to disruption by new technological developments. Disruption always means opportunity and interventionalists must therefore understand AI and be a central part of decision-making when such systems are developed, trained, and implemented. Furthermore, interventional radiologist must not only embrace but lead the change that AI technology will allow. The CIRSE position paper discusses the status quo as well as current developments and challenges.

Research in interventional oncology: How sound is the evidence base?

INTRODUCTION: Interventional oncology (IO) is an essential component of cancer care, which has gained substantial recognition in recent years. The aim of this review is to evaluate the level of evidence supporting IO and its inclusion in cancer treatment guidelines. METHODS: A literature search of the PubMed database was performed to identify publication numbers and types for IO treatments published between 2012 and 2022. Selected cancer treatment guidelines and recommendations were reviewed for their inclusion of IO treatments. RESULTS: With 68%, the majority of studies on IO treatments are case reports while randomised controlled trials (RCTs) amount only to 7% of studies. Despite this, IO studies have generated sufficient data to support the inclusion of IO treatments in cancer treatment guidelines and recommendations. This was frequently based on large prospective patient cohorts that corresponded to 24% (20% non-randomised studies and 4% observational studies) of all analysed studies rather than RCTs. CONCLUSION: The level of evidence underpinning IO, as well as inclusion of IO in treatment guidelines and recommendations have increased substantially in recent years, indicating the growing importance and acceptance of IO in cancer care. The difficulty in conducting RCTs in IO is mitigated by the observation that they are not necessary to achieve guideline-inclusion. Nevertheless, it is crucial to conduct well-designed research projects to further consolidate the position of IO in the field of oncology. This will ensure that IO continues to evolve and meet the needs of cancer patients worldwide.

Standardizing lymphangiography and lymphatic interventions: a preclinical in vivo approach with detailed procedural steps.

PURPOSE: To present a preclinical in vivo approach for standardization and training of lymphangiography and lymphatic interventions using a pictorial review. MATERIALS AND METHODS: Different lipiodol- and gadolinium-based lymphangiography and lymphatic interventions were performed in twelve (12) landrace pigs with a mean bodyweight of 34 ± 2 kg using various imaging and guiding modalities, similar to the procedures used in humans. The techniques used were explicitly introduced and illustrated. The potential applications of each technique in preclinical training were also discussed. RESULTS: By applying visual, ultrasonography, fluoroscopy, CT, cone-beam CT, and/or MRI examination or guidance, a total of eleven techniques were successfully implemented in twelve pigs. The presented techniques include inguinal postoperative lymphatic leakage (PLL) establishment, interstitial dye test, five types of lymphangiography [incl. lipiodol-based translymphatic lymphangiography (TL), lipiodol-based percutaneous intranodal lymphangiography (INL), lipiodol-based laparotomic INL, lipiodol-based interstitial lymphangiography, and interstitial magnetic resonance lymphangiography (MRL)], and four types of percutaneous interventions in the treatment of PLL [incl. thoracic duct embolization (TDE), intranodal embolization (INE), afferent lymphatic vessel sclerotherapy (ALVS), and afferent lymphatic vessel embolization (ALVE)]. CONCLUSION: This study provides a valuable resource for inexperienced interventional radiologists to undergo the preclinical training in lymphangiography and lymphatic interventions using healthy pig models.

Safety, Feasibility and Technical Considerations from a Prospective, Observational Study-CIREL: Irinotecan-TACE for CRLM in 152 Patients.

CIREL, a prospective, Europe-wide, observational study aimed to assess the real-world feasibility and tolerability of irinotecan-based transarterial chemoembolization (LP-irinotecan TACE) for unresectable colorectal cancer liver metastases with regard to the treatment plan and adverse events (AEs). CIREL enrolled 152 eligible patients (≥18 years) with liver-only or dominant metastases treated with LP-irinotecan TACE following a multidisciplinary tumor board decision. Data were prospectively collected for baseline, the number of planned and performed sessions, and technical information and safety according to CTCAE 4.03/5.0. Results from 351 analyzed treatment sessions showed technical success for 99% of sessions, and 121 patients (79%) completed all planned sessions. Further, 60% of sessions were performed using opioids, 4% intra-arterial anesthetics, and 25% both. Additionally, 60% of patients experienced at least one peri-interventional AE of any grade; 8% of grade 3−4. Occurrence of AEs was related to larger liver-involvement (p < 0.001), bi-lobar disease (p = 0.002), and larger beads (p < 0.001). Using corticosteroids together with antiemetics showed reduced and lower grade vomiting (p = 0.01). LP-irinotecan TACE was tolerated well and had a high proportion of completed treatment plans. This minimally invasive locoregional treatment can be used together with concomitant systemic therapy or ablation.

[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.

Single-energy versus dual-energy imaging during CT-guided biopsy using dedicated metal artifact reduction algorithm in an in vivo pig model.

PURPOSE: To evaluate dual-energy CT (DE) and dedicated metal artifact reduction algorithms (iMAR) during CT-guided biopsy in comparison to single-energy CT (SE). METHODS: A trocar was placed in the liver of six pigs. CT acquisitions were performed with SE and dose equivalent DE at four dose levels(1.7-13.5mGy). Iterative reconstructions were performed with and without iMAR. ROIs were placed in four positions e.g. at the trocar tip(TROCAR) and liver parenchyma adjacent to the trocar tip(LIVER-1) by two independent observers for quantitative analysis using CT numbers, noise, SNR and CNR. Qualitative image analysis was performed regarding overall image quality and artifacts generated by iMAR. RESULTS: There were no significant differences in CT numbers between DE and SE at TROCAR and LIVER-1 irrespective of iMAR. iMAR significantly reduced metal artifacts at LIVER-1 for all exposure settings for DE and SE(p = 0.02-0.04), but not at TROCAR. SNR, CNR and noise were comparable for DE and SE. SNR was best for high dose levels of 6.7/13.5mGy. Mean difference in the Blant-Altman analysis was -8.43 to 0.36. Cohen's kappa for qualitative interreader-agreement was 0.901. CONCLUSIONS: iMAR independently reduced metal artifacts more effectively and efficiently than CT acquisition in DE at any dose setting and its application is feasible during CT-guided liver biopsy.

Percutaneous Irreversible Electroporation for Treatment of Small Hepatocellular Carcinoma Invisible on Unenhanced CT: A Novel Combined Strategy with Prior Transarterial Tumor Marking.

INTRODUCTION: To explore the feasibility, safety, and efficiency of ethiodized oil tumor marking combined with irreversible electroporation (IRE) for small hepatocellular carcinomas (HCCs) that were invisible on unenhanced computed tomography (CT). METHODS: A retrospective analysis of the institutional database was performed from January 2018 to September 2018. Patients undergoing ethiodized oil tumor marking to improve target-HCC visualization in subsequent CT-guided IRE were retrieved. Target-HCC visualization after marking was assessed, and the signal-to-noise ratios (SNRs) and contrast-to-noise ratios (CNR) were compared between pre-marking and post-marking CT images using the paired t-test. Standard IRE reports, adverse events, therapeutic endpoints, and survival were summarized and assessed. RESULTS: Nine patients with 11 target-HCCs (11.1-18.8 mm) were included. After marking, all target-HCCs demonstrated complete visualization in post-marking CT, which were invisible in pre-marking CT. Quantitatively, the SNR of the target-HCCs significantly increased after marking (11.07 ± 4.23 vs. 3.36 ± 1.79, p = 0.006), as did the CNR (4.32 ± 3.31 vs. 0.43 ± 0.28, p = 0.023). In sequential IRE procedures, the average current was 30.1 ± 5.3 A, and both the delta ampere and percentage were positive with the mean values of 5.8 ± 2.1 A and 23.8 ± 6.3%, respectively. All procedures were technically successful without any adverse events. In the follow-up, no residual unablated tumor (endpoint-1) was observed. The half-year, one-year, and two-year local tumor progression (endpoint-2) rate was 0%, 9.1%, and 27.3%. The two-year overall survival rate was 100%. CONCLUSIONS: Ethiodized oil tumor marking enables to demarcate small HCCs that were invisible on unenhanced CT. It potentially allows a safe and complete ablation in subsequent CT-guided IRE.

A reporting and analysis framework for structured evaluation of COVID-19 clinical and imaging data.

The COVID-19 pandemic has worldwide individual and socioeconomic consequences. Chest computed tomography has been found to support diagnostics and disease monitoring. A standardized approach to generate, collect, analyze, and share clinical and imaging information in the highest quality possible is urgently needed. We developed systematic, computer-assisted and context-guided electronic data capture on the FDA-approved mint LesionTM software platform to enable cloud-based data collection and real-time analysis. The acquisition and annotation include radiological findings and radiomics performed directly on primary imaging data together with information from the patient history and clinical data. As proof of concept, anonymized data of 283 patients with either suspected or confirmed SARS-CoV-2 infection from eight European medical centers were aggregated in data analysis dashboards. Aggregated data were compared to key findings of landmark research literature. This concept has been chosen for use in the national COVID-19 response of the radiological departments of all university hospitals in Germany.

The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis.

PURPOSE: Transarterial chemoembolisation (TACE) using irinotecan-eluting beads is an additional treatment option for colorectal cancer liver metastases (CRLM) patients that are not eligible for curative treatment approaches. This interim analysis focuses on feasibility of the planned statistical analysis regarding data distribution and completeness, treatment intention, safety and health-related quality of life (HRQOL) of the first 50 patients prospectively enrolled in the CIrse REgistry for LifePearl™ microspheres (CIREL), an observational multicentre study conducted across Europe. METHODS: In total, 50 patients ≥ 18 years diagnosed with CRLM and decided to be treated with irinotecan-eluting LifePearl™ microspheres TACE (LP-irinotecan TACE) by a multidisciplinary tumour board. There were no further inclusion or exclusion criteria. The primary endpoint is the categorisation of treatment intention, and secondary endpoints presented in this interim analysis are safety, treatment considerations and HRQOL. RESULTS: LP-irinotecan TACE was conducted in 42% of patients as salvage therapy, 20% as an intensification treatment, 16% as a first-line treatment, 14% a consolidation treatment and 8% combination treatment with ablation with curative intent. Grade 3 and 4 adverse events were reported by 4% of patients during procedure and by 10% within 30 days. While 38% reported a worse, 62% reported a stable or better global health score, and 54% of patients with worse global health score were treated as salvage therapy patients. CONCLUSION: This interim analysis confirms in a prospective analysis the feasibility of the study, with an acceptable toxicity profile. More patients reported a stable or improved HRQOL than deterioration. Deterioration of HRQOL was seen especially in salvage therapy patients. TRIAL REGISTRATION: NCT03086096.

A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL.

BACKGROUND: About 70-80% of patients with colorectal liver metastases appear as ineligible for a curative treatment approach. Transarterial chemoembolisation (TACE) using irinotecan-eluting beads has emerged as a promising treatment option in cases with irresectable liver metastases. Despite being in clinical practice for years, little is known about the treatment characteristics and outcomes when used as per routine hospital practice. METHODS: Patients with hepatic metastases from colorectal cancer origin, admitted to contributing centres to receive TACE with drug-eluting LifePearl® Microspheres loaded with irinotecan, as part of their standard care, will be consecutively added to the registry. Data will be collected until the end of study, loss to follow-up or death. Primary endpoint is the characterisation of the treatment usage at the selected sites in Europe. Secondary endpoints include outcome parameters, safety and toxicity, as well as quality of life. CONCLUSION AND AIMS: This multicentre, international, prospective observational study conducted in European centres plans to collect real-life data. This data will form an evidence-base from which conclusions can be drawn on how to improve patient selection and optimise treatment protocols when treating with TACE using irinotecan-eluting microspheres. Trial registration NCT03086096.

CIRSE Standards of Practice on Thermal Ablation of Liver Tumours.

This CIRSE Standards of Practice document reviews current literature and provides best practices for image guided thermal ablation of liver tumours, including radiofrequency, microwave and cryoablation techniques.

Transarterial chemoembolisation of colorectal liver metastases with irinotecan-loaded beads: What every interventional radiologist should know.

The last decade has seen important developments in the treatment of metastatic colorectal cancer (mCRC). In this scenario, interventional locoregional treatments could play an expanding role offering safe and effective integrated options in the continuum-of-care offering curative as well as palliative approaches. Based on ESMO guidelines, the toolbox of ablative treatments also includes intra-arterial palliative options, like chemoembolization, that can be offered as an alternative option in patients failing the available chemotherapeutic regimens. However, to date, there is still a limited use of chemoembolization in clinical practice. Based on this background, a comprehensive review of the methodologic and technical considerations as well as clinical indications and future perspectives seems to be useful with the aim to demonstrate the field's value of the procedure, highlight their advantages, and ensure an increased role in treatment management of patients with colorectal liver metastases.