Clinical trials

The possibility of body donation in hereditary hemorrhagic telangiectasia (HHT) means that human tissue samples with and without vascular malformations can be analyzed. The aim is to gain insights into the disease mechanism.

The aim of the study is to use standardized questionnaires to systematically record influencing factors or predictors for suicidal behavior in glioblastoma patients, particularly with regard to existing depression and anxiety symptoms.

Patients with grade 2 and 3 gliomas who received photon radiation therapy as part of their standard treatment are at risk of developing cognitive impairments, depending on the tumor's location and the size of the target volume. The extent to which these are caused in individual cases by the brain tissue within the target volume, which is necessarily exposed to a high dose, or whether they can be modified by differences in the exposure of surrounding brain regions exposed to low or moderate doses, is unknown. With the help of proton therapy, the risk of neurocognitive dysfunction could potentially be reduced by decreasing the brain volumes outside the target volume that are exposed to radiation therapy and receive a low dose. Based on current knowledge of relative biological effectiveness, the efficacy of proton therapy on the tumor compared to photon therapy can be considered equivalent with lower levels of uncertainty. In the present study, the impact of photon irradiation versus proton irradiation on neurocognition will now be directly compared. A bicentric, randomized study will investigate whether treating patients with WHO Grade 2 and 3 gliomas with proton radiation results in a different temporal course of neurocognitive function after treatment compared to photon radiation therapy.

Patients are referred for theranostic PET using different tracers as part of clinical routine for tumor staging, re-staging, and therapy planning to our department. The aim of this study is to collect data on the expression of target molecules/receptors, proportion of PET positive tumor regions, positive predictive value, detection rate, reproducibility, and impact on clinical management of theranostic PET/CT or PET/MRI using novel theranostic PET tracers or other established PET tracers that are performed in theranostic concepts on patients receiving this imaging modality as part of clinical standard both at initial diagnosis and restaging before treatment decisions. Primary Endpoint: Association between PET uptake intensity in theranostic PET and histopathologic expression of the respective molecular target.

Interventional study to compare standard of care vs standard of care plus the use of a medication therapy management smartphone app (mediteo m+, Mediteo GmbH, Heidelberg) in patients with atherosclerotic cardiovascular disease and indication to start high intensity statin therapy.

In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma. We hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior local control, overall and progression free survival. In an additional experimental setting based on patient preference the immunological effectiveness of the adoptive transfer of autologous polyclonal cytomegalovirus (CMV) specific T cells will be examined.

The goal of this observational study is to pursue a multimodal approach to identify the molecular signatures and immune signalling molecules of various myocardial diseases and thereby contribute to improving diagnosis and therapy. The main aim is: -Identification of molecular profiles (e.g., proteome, lipidome, metabolome) and immune signalling profiles that are specifically associated with different myocardial diseases and the post-heart transplantation course. Participants already receiving an endomyocardial biopsy as part of their regular medical care will be enrolled. An additional biopsy sample will be taken for the above mentioned research.

The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process of patients who have had a medical device implanted. These devices include pacemakers for the treatment of bradycardia, implantable cardioverter-defibrillators (ICDs) for the treatment of tachycardia in primary and secondary prevention, and cardiac resynchronization therapy (CRT) devices and event recorders. The study will analyze the influence of stress on the postoperative course, potential complications, and overall quality of life. A combination of medical examinations and surveys will be used to analyze how psychological stress influences the physical healing process and which measures can contribute to improving quality of life and treatment success. The surgical procedure for implanting devices is not part of the study; this is an observational study.

The primary objective of this study is to determine the feasibility of four weeks of preoperative antibody therapy with amivantamab. Amivantamab will be administered as monotherapy (stage 1), and combined with carboplatin/pemetrexed chemotherapy (stage 2). Study treatment is followed by standard of care surgery, and (if clinically indicated) standard of care adjuvant therapy (chemotherapy, radiotherapy, EGFR tyrosine kinase inhibitor therapy) in patients with early stage or locally advanced non-small-cell lung cancer harboring oncogenic EGFR mutations who are eligible for curative resection.

This study seeks to explore the possible common pathogenesis of both cardiac amyloidosis and Alzheimer's disease, which can both be associated with amyloid deposits. Using Positron Emission Tomography (PET) scans with amyloid tracers - a conventional tool for non-invasively imaging amyloid deposits in Alzheimer's disease - the research will extend this imaging methodology to the heart. The study will conduct additional PET/MRI scans of the heart in patients undergoing amyloid tracer PET scans for Alzheimer's evaluations. Each participant will also undergo an echocardiogram and a clinical examination of dementia. This could potentially enhance diagnostic practices in both cardiac amyloidosis and Alzheimer's disease.

Exploration of prognostic parameters in 18F-Florbetaben PET/MRI in patients with cardiac amyloidosis. The clinical endpoints are defined as occurence of major adverse cardiac events (MACE) in amyloidosis patients. Additionally, MACE outcome stratified by PET parameters will be evaluated and individual parameters of the imaging techniques will be compared to each other (PET, MRI or echocardiography).

Typical symptoms of PAD include exercise-induced pain in the legs (known as intermittent claudication), which can significantly limit pain-free walking. In more advanced stages, pain may also occur at rest. Additionally, the development of chronic, hard-to-heal wounds-especially on the feet and toes-is possible. These wound healing impairments are caused by the insufficient supply of oxygen and nutrients to the affected tissues. The underlying cause of PAD is usually atherosclerosis, a pathological change in the vessel walls due to the accumulation of fats, calcium, and connective tissue. These deposits lead to stiffening and narrowing of the arteries, severely restricting blood flow. Major risk factors for the development of PAD include widespread chronic conditions such as diabetes mellitus, hyperlipidemia (elevated blood lipid levels, e.g., cholesterol), arterial hypertension (high blood pressure), obesity, and tobacco use. Various therapeutic options are available for the treatment of PAD. In addition to conservative therapy (such as supervised exercise training, pharmacological blood thinning, and risk factor management), interventional, minimally invasive treatment using catheter-based techniques is frequently employed. In such procedures, a thin catheter is guided through the vascular system to the affected area of the leg artery. Depending on the type and extent of the arterial narrowing or calcification, one of the following techniques may be applied: Balloon angioplasty: Dilation of the vessel using an inflatable balloon. Lithoplasty: Application of shockwaves to break down calcifications in the arterial wall.

The Essen Amyloidosis Registry (EAR) is a prospective, observational registry designed to collect comprehensive clinical data on patients diagnosed with systemic amyloidosis. The registry aims to improve the understanding of disease progression, diagnostic pathways, and treatment outcomes. The registry is hosted at the University Hospital Essen and follows patients longitudinally. Inclusion is open to all patients with suspected or confirmed amyloidosis who provide informed consent.

Atherosclerotic cardiovascular disease is the leading cause of morbidity and mortality worldwide. Patients with peripheral arterial disease are at increased risk suffering from major adverse cardiac and limb events. Acute and chronic stress affect the cardiovascular system. Long-term negative stressors lead to cardiovascular diseases and can aggravate already existing cardiovascular diseases. However, current guidelines on cardiovascular disease prevention highlight stress as a cardiovascular risk factor there is a lack of consensus about the definition and measurement of stress. The aim of the proposed trial is to evaluate different stress measuring methods in patients with PAD depending on the occurrence of cardiovascular events.

The ECAD registry is a registry of patients undergoing coronary angiography at the West German Heart and Vascular Center. The registry anticipates to determine predictors of patient outcome after coronary angiography.

Patients with hereditary hemorrhagic telangiectasia (HHT) suffer from an inherited disorder leading to systemic vascular malformations. Mutations in several genes of the transforming growth factor (TGF)-β superfamily pathway influence angiogenesis in patients with HHT. The genetic loss of ALK1 or ENG alone are not sufficient to induce AVMs; environmental insults that could trigger angiogenesis (e.g. wounding) are also needed. In this study it will be analyzed if hypoxic induced factors could have an influence on the disease HHT.

The long-term goal is to define "signatures" in the form of genomic changes through sequence analyses of genomic DNA using modern Next Generation Sequencing (NGS) methods, which 1. determine the radiation exposure of humans. 2. provide information about the exposure (dose). 3. determine the radiation quality. 4. predict the repair capacity and radiation resistance of an individual.

There is a prospective risk-adapted evaluation of the optimal dose of radiotherapy for definitive radiotherapy of locally advanced small cell lung cancer within the corridor recommended as standard therapy according to the current interdisciplinary S3 guideline of the German Cancer Society/Cancer Aid/AWMF

Most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. If the field-set UP margins are broad, the consequence may be that quality of life is impaired. The study group of Nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard IMRT (Nutting C, Finneran L, Roe J, Petkar I, Rooney K, Hall E; DARS Triallist Group. Dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - Authors' reply. Lancet Oncol. 2023 Oct;24(10):e398. doi: 10.1016/S1470-2045(23)00457-6. PMID: 37797636.) The study group concluded that the results suggest that dysphagia-optimized IMRT improves patient-reported swallowing function compared to standard IMRT. DO-IMRT should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and ART could further improve outcomes.

Adaptive radiotherapy (ART) includes image-guided radiotherapy (IGRT) and also offers further possibilities for plan adaptation. A particularly high benefit can be expected for patients in whom the clinical target volume (CTV) can show a significant change in shape from fraction to fraction due to anatomical deviations. The shape and position constancy of the CTV during the course of the series is examined in this trial. Dosimetric disadvantages of this type have not been reported so far. The aim of this study is to identify patients who benefit from ART at an early stage and to select them for this method, and then to continue to offer ART to this patient group. If a relevant reduction in the minimum planning target volume (PTV) margins with ART compared to IGRT is demonstrated in this study, patients could be treated with ART.

The HIV/HEART Aging study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to October 2022 (15 year Follow-up) 1858 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far. The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches. The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.

Background: PROMISE criteria have been defined for standardized reporting of Prostate-Specific Membrane Antigen (PSMA) PET whole-body stage of prostate cancer. PSMA PET disease extent by PROMISE has been associated with oncologic outcome. Need: Improved prognostication across various stages of prostate cancer is needed for management guidance and study design. Aim: 1. To assess the prognostic value of PSMA PET 2. To compare the prognostic value of PSMA PET with clinical prognostic scores in patients with prostate cancer at various disease stages Inclusion: * Adult patients with * biopsy/histo proven prostate cancer who * underwent PSMA PET (any type) * for staging or re-staging at any stage and who * have at least 3-year overall survival follow-up data available will be included consecutively. Exclusion: * Patients with neuroendocrine prostate cancer * Patients with metastasized or disseminated malignancy other than prostate cancer

Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.

This is a prospective observational trial investigating correlation with histopathology, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI in patients receiving this imaging modality for tumor staging or restaging as part of clinical care.