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  • Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)

    Background: Stereotactic body radiotherapy (SBRT) for localized prostate cancer has demonstrated non-inferior oncological outcomes and toxicity profiles to conventionally or moderately hypofractioned radiotherapy regimens, while offering the advantage of shorter treatment durations. However, SBRT may not be suitable for all patients, particularly those with lower urogenital tract symptoms and/or prostatic hyperplasia. Methods: This study aims to evaluate the safety and efficacy of weekly computed tomography (CT) or magnetic resonance image-guided (MRI) online adaptive SBRT in patients with intermediate to (very) high-risk localized prostate cancer who present with lower urinary tract symptoms (International Prostate Symptom Score [IPSS] > 12) and/or have prostate hyperplasia (prostate volume >60 mL). The primary outcome measure is urogenital toxicity grade ≥3 within 3 months after completion of SBRT (according to CTCAE V5.0 and RTOG) or discontinuation of therapy. Our aim is to show that the event rate is at 3% below a clinically acceptable threshold, which is set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30.

    Phase

    N/A

    Span

    379 weeks

    Sponsor

    University of Zurich

    Munich, Bavaria

    Recruiting

  • A Prospective, Bicentric Evaluation of Fluciclovine PET-imaging in Patients with Prior Negative or Inconclusive PSMA-ligand PET

    The REFINE study is a prospective, bicentric observational trial conducted at two specialized nuclear medicine centers in Germany to evaluate the technical performance of fluciclovine (18F) PET/CT imaging in a real-world clinical setting. Patients with prostate cancer recurrence after definitive treatment who previously underwent a negative or inconclusive PSMA PET/CT are enrolled and observed for 12 months. Each participant undergoes a fluciclovine PET/CT scan as part of their normal clinical routine, with all images pseudonymized and stored in a central database where three independent nuclear medicine physicians, blinded to the local site's interpretation, review each scan. In addition to the initial imaging, follow-up assessments are conducted at one month and 12 months to validate scan findings; a questionnaire sent to the referring physician at one month helps capture any changes in the intended treatment plan, while comprehensive follow-up data-including additional imaging studies, PSA levels, treatment outcomes, and histopathological findings when available-are collected at 12 months. This follow-up information serves as a composite reference standard to distinguish true positive lesions from false positives, with criteria based on changes in lesion size, response to treatment, and confirmatory imaging or biopsy results, as well as to identify any false negatives.

    Phase

    N/A

    Span

    148 weeks

    Sponsor

    Technical University of Munich

    Munich, Bavaria

    Recruiting

  • Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

    Phase

    N/A

    Span

    1357 weeks

    Sponsor

    University Hospital of Cologne

    Munich, Bavaria

    Recruiting

  • European Registry of Next Generation Imaging in Advanced Prostate Cancer

    This registry is intended to collect real-world data on patient demographics, medical history, clinical endpoints, histological tumour characteristics and imaging explorations of the patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration (conventional, NGI, or their combination) either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment. Stage 1: cross-sectional observation 1. To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria. 2. Assess management prompted by NGI vs. conventional imaging in usual clinical practice. 3. To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria. 4. Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed. 5. Reclassification of HSPC (M0 vs low vs. high volume) based on NGI respect to CI when both imaging modalities are used. Stage 2: longitudinal observation 1. Evaluation of survival outcomes and their relationship with the imaging pathway undertaken (overall and per subgroup of imaging modality). 2. Identification of prognostic factors related to treatment response and disease progression.

    Phase

    N/A

    Span

    119 weeks

    Sponsor

    Fundacio Puigvert

    Munich

    Recruiting

  • Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

    The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF). VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm. No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study. The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively. The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.

    Phase

    N/A

    Span

    148 weeks

    Sponsor

    Volta Medical

    Munich

    Recruiting

  • Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging

    Melanin, a pigment found in the skin, has been reported to influence light-based measurements such as pulse oximetry or near-infrared spectroscopy (NIRS). Studies have shown measurements overestimation of darker skin tones or in ethnicities assumed to have darker skin tones compared to lighter skin tones. Even though optoacoustic imaging (OAI) has a different depth penetration than NIRS or pulse oximetry, the technology uses pulse laser light to assess tissue. Multispectral Optoacoustic Tomography (MSOT) imaging is similar to conventional sonography: a transducer is placed on the skin, and instead of sound, energy is applied to the tissue by means of pulsed laser light. This leads to a constant change of minimal expansion and contraction of individual tissue components or molecules. The resulting sound waves can then be detected by the same device. Previous studies have already shown that the quantitative determination of hemoglobin can provide information on inflammatory activities or muscle hemodynamics. MSOT uses laser light between 660 and 1300nm to visualize and quantify different endogenous chromophores, such as hemoglobin, collagen, or melanin. Increase in melanin concentration (e.g. in melanomas or skin tags) has been previously assessed using the technology but never looked at signal at depth. Additionally, differences in body-mass-index (BMI) might influence light penetration, and therefore, the optoacoustic signal at depth. So far, no studies have looked at the influence of increased melanin concentration or subcutaneous fat on quantification of muscle perfusion and oxygenation. In this first pilot study, the aim is to investigate the influence of different Fitzpatrick skin phenotypes (FSP) and BMI on muscle perfusion and oxygenation during arterial occlusion or muscle exercise and over time. This information is essential for further studies with a more diverse study population. To gain insights into these differences, healthy volunteers with different skin tone (defined by FSP) and body-mass-index will be recruited and subjected to a leg arterial occlusion and to perform a toe raise exercise. They will then be scanned on different body areas (arm, legs) to assess changes in muscle perfusion and oxygenation by MSOT.

    Phase

    N/A

    Span

    81 weeks

    Sponsor

    University of Erlangen-Nürnberg Medical School

    Munich, Bavaria

    Recruiting

    Healthy Volunteers

  • Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)

    This study will be conducted in multiple sites in North America, Europe, Middle East and South America.

    Phase

    3

    Span

    124 weeks

    Sponsor

    Mirum Pharmaceuticals, Inc.

    Munich

    Recruiting

  • The TRICURE EU Pivotal Study

    The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

    Phase

    N/A

    Span

    331 weeks

    Sponsor

    TRiCares

    Munich

    Recruiting

  • 40 Hz Visual Stimulation As an Intervention in Schizophrenia

    SAMPLE Inward patients at Klinikum rechts der Isar, Munich, Germany diagnosed with schizophrenia (F20) or a schizoaffective disorder (F25) will be recruited. Treating physicians will screen and pre-select patients who are primarily affected by negative symptoms and on stable medication and/or psychotherapy (treatment as usual) throughout the study period. The target sample size for this pilot is at least N = 10 patients who undergo the experimental study protocol, and an equal number of patients who only complete the scales as a treatment-as-usual control group. PROTOCOL - EXPERIMENTAL GROUP The protocol for the experimental group will be as follows. After written informed consent was obtained by their treating physician, patients will undergo session 0 for pre-tests five to one day(s) before the first stimulation session. For a fair comparison with the post-tests in the last session, patients will be asked not to drink coffee in the three hours beforehand, to rest at the lab for one hour, and then to complete the mood and cognition scales (PANAS and THINC-IT). The psychiatric symptom assessment (PANSS) will be carried out by their treating physician before the first stimulation in session 1. The stimulation protocol will take place the week after, from Monday to Friday, at approximately the same time of day as session 0. Patients should again avoid consuming coffee three hours before each session start, to facilitate sleep. In session 1 (Monday), the EEG will first be set up. The session will start with a five-minute resting-state EEG recording; then, patients will lay down and undergo the visual stimulation protocol with their eyes closed for one hour. They will be encouraged to relax and fall asleep during this time. Afterward, we will inquire about adverse events and the EEG will be removed. In sessions 2 to 4 (Tuesday to Thursday), no EEG will be recorded. Patients will undergo one hour of visual stimulation and subsequently be asked about adverse events in the same way as in session 1. In the last session 5, the protocol will be the same as in session 1, including EEG, five minutes of resting-state recording, and one hour of visual stimulation. Afterward, as in session 0, patients will also complete the mood and cognition scales (PANAS and THINC-IT). The psychiatric symptom assessment (PANSS) will be carried out by their treating physician zero to three days after the last stimulation session. PROTOCOL - CONTROL GROUP As for the control group, after written informed consent was obtained by their treating physician, patients will undergo session 0 analogously to the experimental group for the pre-tests. This procedure will be repeated 7-10 days later for the post-tests. VISUAL STIMULATION Visual stimulation parameters will be analogous to a previous study (Hainke et al., 2025). A customized sleep mask with inbuilt LEDs externally linked to a microcontroller will be used to deliver visual stimuli. Its high-wavelength LEDs with a narrow spectral peak at 605 nm and an illuminance of 80 lux will flicker at 40 Hz in a square wave pattern at a 50 % duty cycle. Light will be faded in at the beginning and out at the end for 10 seconds, respectively. Patients will be asked to keep their eyes closed and encouraged to fall asleep for the full stimulation duration of 60 minutes. After every stimulation session, the experimenter will verbally inquire about adverse events, by asking the patient: "Have you experienced any undesired effects during or after the stimulation?". If the patient answers yes, they will be asked to describe the adverse event and then rate its severity as mild, moderate or severe and whether it was unlikely, likely or certainly related to the stimulation. For the resting-state measurement, the LEDs will be flickering at 40 Hz as during the stimulation, but they will be covered with black tape ("blackout"). This controls for the possibility of electrical interference from the mask on EEG data (Hainke et al., 2025). Here, patients will remain awake. EEG SETUP EEG will be measured in the experimental group at sessions 1 and 5 using the Neurofax system at the clinic's sleep laboratory, supported by Polaris.One software (Nihon Kohden Europe GmbH, Rosbach v.d.H., Germany). The sampling rate will be 1000 Hz. Gold cup electrodes will be positioned at A1, A2 (mastoids reference), FpZ (ground), left EOG, left EMG, C3, C4, O1, Oz, O2, PO3, POz, and PO4. Sleep scoring will be performed automatedly and offline using the Python library YASA based on the C4, EOG, and EMG electrodes, and participants' sex and age (Vallat & Walker, 2021). EEG PROCESSING Data will be pre-processed using MNE Python as in Hainke et al. (2025): Band-pass filtering (0.16-300 Hz) Bad channel rejection by visual inspection Electrode averaging by Region of Interest: central (C3, C4) and occipital (O1, Oz, O2, PO3, POz, PO4) Re-referencing to the mastoid average (A1, A2) Dividing data into 30-second epochs Bad epoch rejection (<50% sleep scoring algorithm certainty or stimulation duration <25 seconds) For frequency domain analyses, epochs with a peak to peak amplitude > 1 mV will be rejected. All 30-s epochs will be subjected to a Fast-Fourier Transform using a Hamming window to obtain the Power Spectral Density per epoch. For time domain analyses, data will be further divided into 25 ms segments length of one cycle of a 40 Hz oscillation); segments with a peak-to-peak amplitude >100 μV will be rejected. 30-s epochs and 25-ms segments will be averaged by region of interest (central / occipital), condition (blackout / stimulation), session (1 / 5), and state (awake / light sleep / deep sleep). Light sleep is defined as NREM1 and NREM2; deep sleep is defined as NREM3. EEG OUTCOMES The two resulting EEG outcomes describe the Steady-State Visually Evoked Potentials (SSVEPs), i.e., the magnitude of the neuronal response to 40 Hz visual stimulation, from complementary perspectives. EEG signals can be interpreted in the time domain or the frequency domain; analysing both allows for maximal information gain about underlying neuronal processes (Hainke et al., 2025). In the time domain, SSVEP magnitude is quantified as the peak-to-peak amplitude of the 25-ms segment average in microvolts. In the frequency domain, SSVEP magnitude is quantified as the signal-to-noise ratio of power at 40 Hz, i.e., the power spectral density value at 40 Hz in dB divided by the surrounding values [38 to 39.5 Hz] + [40.5 to 42 Hz] in dB. COGNITIVE & PSYCHIATRIC OUTCOMES The following scales will be completed by both the experimental and control group patients, in the respective first and last session. Cognition will be assessed with the THINC-integrated tool test battery (THINC-IT; Harrison et al., 2018), presented on a Windows laptop. It has previously been used to assess cognition in schizophrenia (Szmyd et al., 2023) and has five components: Spotter (Choice Reaction Time), Symbol Check (1-back test), Trails (Trails Making Test B), Codebreaker (Digit Symbol Substitution Test), and a self-reported cognitive function questionnaire (5-item Perceived Deficit Questionnaire). Mood will be measured with the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988). The Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987) will be administered by a trained physician to quantify schizophrenia-related psychiatric symptoms. An interim analysis will be conducted when a sample of 10 patients in the experimental group has been reached.

    Phase

    N/A

    Span

    20 weeks

    Sponsor

    Technical University of Munich

    Munich, Bavaria

    Recruiting

  • CRS Questionnaire Validation Project

    The objectives of this study are as follows: - Validation of two new questionnaires with the aim of measuring the current perceived condition of a patient with chronic rhinosinusitis in terms of control and severity. - Validation of these questionnaires in routine medical settings. - Evaluation of the results of these questionnaires in comparison with other tools currently available.

    Phase

    N/A

    Span

    57 weeks

    Sponsor

    The European Forum for Research and Education in Allergy and Airway Diseases

    Munich

    Recruiting

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