Interventional Radiology Research (IR2)

Planning and (Intraprocedural) treatment Evaluation (π)

IAMCOMPLETE study

After surgical resection of liver tumors, pathological examination of the resected tissue is performed to confirm treatment success and determine safety margins. After percutaneous liver tumor ablation, treatment success and safety margins can only be estimated using medical imaging. In the IAMCOMPLETE study, our in-house co-registration software deLIVERed is used for three-dimensional assessment of ablation margins. Contrast-enhanced CT scans are acquired immediately before and after thermal ablation for hepatocellular carcinoma according to an optimized scanning protocol. These CT scans are then co-registered and safety margin quantification is performed by two independent reviewers to determine intra- and interobserver variability and to analyse the relation between safety margins and local recurrence.

PROMETHEUS study

The PROMETHEUS study is a national, prospective, multicentre trial, including patients that undergo thermal ablation for hepatocellular carcinoma. In all patients, bi-phase contrast-enhanced CT is performed immediately before and after thermal ablation during apnoea under general anaesthesia. The pre- and postablation CT-scans are co-registered using our in-house developed software platform deLIVERed to perform quantitative analyses of the ablation margin. The minimal ablation margin is correlated with local recurrence to determine which margin should be obtained to achieve local recurrence rates <10%. LUMC is the lead institute of this trial with the RadboudUMC as participating centre and all other Dutch academic centres as inclusion centres. In this trial, the IR² group, Division of Image Processing (LKEB) and department of Gastroenterology and Hepatology work closely together. Other collaborating partners include the Dutch Oncology Research Platform (DORP), Dutch Hepatocellular and Cholangiocarcinoma Group (DHCG), Dutch association of liver patients (NLV) and Dutch Society of Interventional Radiology (NVIR). The trial is funded by a grant from the Dutch Cancer Society (KWF).

MedTechNL

MedTechNL is a national partnership of university medical centers and other hospitals, technical universities, universities of applied sciences, health care industry and health funds. MedTechNL aims to boost medical-technological research and innovation in the Netherlands, thereby improving the earning capacity of the Dutch business community and strengthening the position of the Netherlands as an international pioneer of medical technical innovations. Image-guided interventions are an essential part of the project. Within MEDTECHNL, the interventional radiology centre of the LUMC is the designated clinical test and validation lab for vascular interventions. The lab consists of five new IR rooms with integrated research facilities and state-of-the-art equipment, including an angio-CT system, three angiography systems with cone-beam CT, fluorescence cameras, FORS technology, ultrasound devices with capability to perform duplex, 3D flow measurements, and intravascular ultrasound, and advanced software packages for image co-registration, navigation and treatment planning. Together with the Division of Image Processing (LKEB) and partners within MEDTECHNL, we will design, validate and optimize software and artificial intelligence solutions that will help treatment decisions based on automatic interpretation and quantification of complex intra-procedural data. 

SELECT study

Compared to non-anatomical limited resections, anatomical resections may reduce local recurrence rates after liver resections by eradication intrasegmental microscopic metastases and satellite modules. Furthermore, anatomical resections may reduce intraoperative blood loss and postoperative bile leakage. Identification of segment that needs to be resected and its borders based on intraoperative ultrasonography may be challenging, especially in laparoscopic procedures. In the SELECT study, indocyanine green will be injected into the segmental artery of the tumor-bearing segment using a transfemoral approach. The segment and its borders will then be recognizable during the operation using fluorescence imaging. The objective of the study is to determine the optimal dose of ICG and best time window between transarterial injection of ICG and liver resection. In this trial, we work closely together with the department of Surgery of the LUMC and Green Light Leiden.

Interventional Oncology combination therapy (IO2)

CHOPIN study

There is a lack of effective treatment options for patients with metastatic ocular melanoma. In previous studies, we have demonstrated that percutaneous perfusion with melphalan (M-PHP) is an effective treatment for ocular melanoma liver metastases. The CHOPIN trial is an open-label, single center, phase Ib/randomized phase II trial, evaluating the safety and efficacy of the combination of M-PHP with ipilimumab (anti-CTLA-4 antibody) and nivolumab (anti-PD-1 antibody) in patients with unresectable ocular melanoma liver metastases in first line treatment, with or without limited extrahepatic disease. The primary objective is to determine safety, toxicity and efficacy of the combination regimen, defined by maximum tolerated dose (MTD) and progression-free survival (PFS) at one year. Secondary objectives include overall survival (OS) and overall response rate (ORR). A maximum of 88 patients will be treated in phase I and phase II combined. In the study, we work closely together with the department of Medical Oncology. Oter collaborating partners include CDR, BMS and Delcath Systems.

HORA EST HCC study

Hepatocellular carcinoma (HCC) patients with a tumor up to 2 cm are best treated with thermal ablation. For larger lesions, surgical resection remains the standard as it yields lower chances of tumor recurrence. However, most of these patients are not eligible to major liver surgery due to their underlying liver disease. In the HORA EST HCC study, thermal ablation is combined with adjuvant transarterial radioembolization in patients with HCC of 2-5cm. The objective of this first-in-man study is to investigated the biodistribution of Holmium-166 (Ho-166) microspheres when used as adjuvant treatment after radiofrequency ablation. Based on these study results, the optimal radiation dose will be established for combination therapy of thermal ablation and Ho-166 radioembolization. The study is funded by ZonMW, Health~Holland and MLDS. For this study, we work closely together with our Nuclear Medicine physicians and the department of Gastroenterology and Hepatology. Collaborating partners include the Dutch Hepatocellular and Cholangiocarcinoma Group (DHCG), Dutch Society of Liver patients (NLV), Quirem Medical B.V. and Medtronic.

New Innovative Therapies & Indications (NiTi)

FLOW study

The evaluation of the effect of angioplasty and or stenting during endovascular treatment of patients with peripheral arterial disease (PAD) is currently performed by qualitative assessment of angiography findings by the treating physician. Intraprocedural hemodynamic assessment of treatment response with transcatheter pressure measurement is rarely performed. A reliable objective hemodynamic parameter would be helpful and may influence treatment strategy during endovascular treatment. The objective of the FLOW study is to compare different techniques to evaluate hemodynamic changes during endovascular treatment in 30 patients with PAD. Objective quantitative intraprocedural assesment of hemodynamic changes may allow more accurate determination of treatment success and is expected to positively influence decision making, vessel patency, costs and patient outcomes. The FLOW study is a collaboration with Philips Medical Systems.

Percutaneous hepatic perfusion studies

Uveal melanoma (UM) is the most common intra-ocular malignant tumor in adults. Up to 50% of patients will develop metastatic disease with the liver being the primary predilection site. Without treatment, metastasized UM has a dismal prognosis. Less than 10% of patients are eligible for resection or thermal ablation, as metastases are often bilobar and diffuse, and there are few systemic options. Percutaneous hepatic perfusion (PHP) is a novel, minimally invasive technique that allows delivery of a high dose of chemotherapeutic drugs to the liver with limited systemic toxicity. The LUMC is the main referral center in the Netherlands for patients with UM and is the only center in the Netherlands offering PHP. In previous studies, we have demonstrated the efficacy and safety of PHP. In on-going studies, we are investigating how to optimize the treatment and periprocedural care and the combination of PHP with immunotherapy (CHOPIN study).