Clinical Research Directory

Percutaneous Thermo-ablation for the Treatment of Prostate Cancer Oligometastatasis (TA-P-OLIM)

The TA-P-OLIM Study (Percutaneous Thermo-Ablation of Prostate Cancer OligoMetastasis) is a prospective, interventional phase II study designed to evaluate the feasibility, efficacy, and safety of percutaneous thermal ablation (TA) as a metastasis-directed therapy (MDT) for patients with oligometastatic prostate cancer. So far, these metastases have been locally treated with stereotactic body radiation therapy (SBRT) or surgical resection. Percutaneous TA is a minimally invasive technique that locally destroys tumor tissue using either heat (via microwave or radiofrequency ablation) or cold (via cryoablation). This is achieved by inserting specialized needles into the tumor through a small skin incision under image guidance. TA offers a valuable treatment option for patients who are not suitable candidates for SBRT, such as those with prior radiation exposure or metastases located near critical anatomical structures. In many of these cases, ablation remains feasible through the use of adjunctive thermoprotection techniques, where fluid is injected via a needle to gently displace critical structures, thereby creating a safe buffer zone during treatment. Preliminary retrospective evidence shows that TA achieves comparable local tumor control rates to SBRT/resection with minimal complications.7 As a minimally invasive procedure, TA typically requires only a brief hospital stay-often on an outpatient basis-and enables rapid recovery. This makes TA an attractive alternative to surgery, which is associated with greater morbidity, longer recovery times, and limited suitability for some patients. In contrast to SBRT, TA also allows for simultaneous tissue sampling which is completed in a single session. Moreover, it can be safely repeated in the event of local recurrence. The study focuses on patient-centered endpoints such as local control and tolerability, aiming to improve quality of life through personalized, minimally invasive treatment strategies. TA also offers an effective local treatment option for patients who are not eligible for standard treatments such as SBRT. In this way, an alternative to both SBRT and surgery is provided, enabling continued local treatment for patients. Patients are eligible if they have previously received radical treatment for prostate cancer (surgery or radiotherapy, with or without hormonal therapy), subsequently developed a limited number of metastases (1-5), and are no longer candidates for or deny SBRT. UZ Ghent, with its long-standing research expertise in metastasis-directed therapies for oligometastatic prostate cancer, coordinates the study. The project was established in collaboration with various departments within the Urological Multidisciplinary Tumor Board. Several centers in East and West Flanders have already confirmed their willingness to participate in the study.

The Safety and Efficacy of Irreversible Electroporation for the Treatment of Perivascular Liver Cancers

Malignant liver tumors are among the most common cancers worldwide, with over 10,000 new cases reported annually in Taiwan. Despite the availability of various treatment options, the prognosis for primary hepatocellular carcinoma and other metastatic liver cancers remains poor, with more than 8,000 deaths each year. The majority of patients (approximately 70%-85%) are diagnosed at an advanced stage or are deemed unresectable. In contrast, patients with small tumors often have a chance of cure. According to numerous studies, patients undergoing hepatic resection achieve a five-year disease-free survival rate exceeding 50%. For patients with unresectable malignant liver tumors who do not have vascular invasion or extrahepatic metastasis, radiofrequency ablation (RFA) serves as an alternative curative treatment. However, a major limitation of RFA lies in its reduced efficacy when tumors are located near blood vessels, making complete ablation difficult. Irreversible electroporation (IRE) offers a safer ablation modality that is unaffected by vascular proximity. Both preclinical and clinical studies have demonstrated that IRE is a safe and effective treatment for liver tumors. According to reports in the international journal Radiology, complete ablation rates of 77.3%-92% have been achieved in patients with liver cancer treated with IRE, with complication rates of around 19%, most of which were mild. The irreversible electroporation ablation system (Irreversible Electroporation Ablation Generator) used in this study delivers an ablation field with a voltage of 3,000 volts. It received U.S. Food and Drug Administration (FDA) approval in 2023 but has not yet been introduced in Taiwan. This study will target patients with malignant liver tumors who are unsuitable for surgical resection but are eligible for local ablation therapy, specifically those with tumors located adjacent to the inferior vena cava, hepatic veins, or within 1 cm of the main trunks of both portal veins. A total of 20 patients will undergo ablation treatment under intubation and general anesthesia. Postoperative monitoring will focus on potential complications, and patients will be followed for four months to assess complete tumor ablation and intrahepatic recurrence, in order to verify the clinical feasibility and advantages of this system.

Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation

This is a prospective, randomized clinical trial evaluating the efficacy and safety of two techniques for repeat catheter ablation in patients with recurrent atrial fibrillation (AF): thermal energy ablation (radiofrequency) and non-thermal electroporation (pulsed field ablation), both guided by 3D imaging systems. Patients undergoing repeat AF ablation will be randomly assigned to receive either thermal or electroporation ablation, performed according to standard hospital protocols. No additional invasive procedures are required. Following the ablation, participants will attend follow-up visits at 3, 6, and 12 months, including medical history review, physical examination, 12-lead ECG, and 24-hour Holter monitoring. Unscheduled ECG assessments will also be available if arrhythmia symptoms occur. All study-related procedures are non-invasive and align with routine post-ablation care. Risks are limited to those typically associated with standard AF ablation procedures. The main benefit of participation is close, structured follow-up by experienced electrophysiologists, allowing for early detection of arrhythmia recurrence and timely medical intervention when necessary. Participant confidentiality and data protection will be ensured in accordance with GDPR regulations.

Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland

The aim of the described project is to establish a multicenter, nationwide registry of atrial arrhythmia ablation procedures using the Pulsed Field Ablation (PFA) method. These procedures have only recently begun to be performed in several centers across Poland. With proper coordination of the registry, this will enable the consolidation of clinical data and the expansion of knowledge regarding the efficacy and safety of these procedures.

MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. In this study, GFMA will be performed on patients who have experienced \> 10% weight loss with GLP-1 therapy and who plan to discontinue use of GLP-1 medications for the duration of the study.

Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease

This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations. The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities.