Bodã¸, Norway
A Clinical Study on the Effect of Discontinuing Alendronate in Postmenopausal Women with Osteoporosis After a Treatment Period Without Fractures
Phase
4Span
239 weeksSponsor
Odense University HospitalOdense
Recruiting
FDG-PET/CT vs. CT for Monitoring Metastatic Breast Cancer
Background Breast cancer is the most commonly diagnosed cancer in Europe and worldwide. With a continuously increasing incidence, it is estimated that by 2040, the breast cancer burden will increase to more than three million new cases per year worldwide, with more than one million breast cancer-related deaths per year (50% increase). The prognosis of breast cancer is steadily improving due to the early detection of primary cancer through screening programs and revolutionising treatment development. Despite this, approximately one-third of patients diagnosed with primary breast cancer will develop metastatic disease. In the metastatic setting, therapy improvements have made breast cancer a chronic disease with declining mortality rates, and several effective treatment lines are available for metastatic breast cancer patients today and in the future. This favourable situation requires accurate methods to assess response to treatment to achieve the most effective treatment planning. FDG-PET/CT is increasingly used in cancer staging. Several studies have shown improved sensitivity of FDG-PET/CT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. We expect FDG-PET/CT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies. This has the potential to increase the beneficial effect of second-line therapies at the individual level and result in a delayed need for third-line therapies, prolonged overall survival, and improved quality of life compared with patients monitored with conventional CT. Currently, no specific recommendations are provided for a diagnostic modality to monitor treatment response in patients with metastatic breast cancer. European clinical practice guidelines (ESMO) state that there is no evidence of any staging or monitoring approach for metastatic breast cancer patients that provides overall survival benefit over another approach. ESMO suggests that FDG-PET/CT might provide earlier guidance in the monitoring of bone-only or bone-predominant metastasis, but it is emphasised that prospective trials are needed to study the impact of this on treatment decisions and overall survival. This is the evidence that MONITOR-RCT will deliver. Study objectives The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT. Secondary objectives of the MONITOR-RCT are to demonstrate superiority with respect to the quality of life and exposure to oncologic treatment and to investigate the cost-effectiveness. Consequently, the primary endpoint of the study is overall survival. Secondary endpoints are quality of life, exposure to oncologic treatment, and cost-effectiveness. Study design The MONITOR-RCT study will be an international multicenter study. The design will be a parallel group comparative randomized trial comparing an experimental monitoring strategy based on FDG-PET/CT with a standard monitoring strategy based on CT. Eight hospital sites in Denmark, two in Italy, and one in Germany will participate in patient recruitment and the conduction of the study. Inclusion criteria Criteria for inclusion will be: Women and men aged ≥18 years Diagnosis of distant relapsed metastatic breast cancer (biopsy-verified) or de novo breast cancer. In patients with distant relapsed metastatic breast cancer, biopsy verification from a distant metastasis is required. In patients with de novo metastatic breast cancer, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of metastatic breast cancer is required. Considered eligible for first-line systemic treatment Considered eligible for continuous treatment monitoring by scans. Signed informed consent Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English. Exclusion criteria Criteria for exclusion will be: Pregnant or lactating women Ongoing oncological treatment for another cancer Exclusively brain metastasis Allergy to FDG Target population Participating patients should have newly diagnosed metastatic breast cancer and be considered eligible for initiating first-line medicinal treatment and subsequent regular response monitoring. This is the patient population for whom a benefit from FDG-PET/CT-based response monitoring is expected. They are very similar to the criteria defining the populations investigated in Vogsen et al. (2023) and Naghavi-Behzad et al. (2022). Quality of life questionnaires Quality of life questionnaires will be completed at home every three months during the first year and every six months later. Two questionnaires will be used: EQ-5D-5L FACT-B In addition, patients can report complaints related to the conduct of scans in a final open question at the end of the questionnaires. Interventions The intervention of interest is the use of FDG-PET/CT for response monitoring compared with CT for response monitoring. The use of CT as a monitoring modality represents the usual care in patients with metastatic breast cancer. FDG-PET/CT scans will be evaluated using the standardized response evaluation criteria for patients with metastatic breast cancer (PREMIO criteria), whereas the CT scan will be evaluated using the RECIST 1.1 criteria. Both criteria aim at classifying the patient as having complete (metabolic) response (CR/CMR), partial (metabolic) response (PR/PMR), stable (metabolic) disease (SD/SMD), equivocal metabolic disease (EMD) or progressive (metabolic) disease (PD). The PREMIO set of response evaluation criteria is an adaptation of PERCIST (for monitoring patients with metastatic breast cancer. The PREMIO criteria are defined based on data from the MESTAR study, Vogsen et al. (2023), introducing the nadir scan for comparison in cases where the disease has regressed compared with the baseline scan. Clinical decision-making: For patients in the intervention group, clinical decision-making will be supported by FDG-PET/CT and PREMIO, while the conventional group will be supported by the CE-CT and RECIST 1.1. The decision-making will be in both groups following the current standard according to the local practice and following international guidelines. The decision-making may include a request for further imaging procedures. Parameters such as toxicity profile and the patient's general condition will also influence treatment decisions. Major components of patient management and the main reasons for treatment decisions will be registered throughout the study. Scan procedure and interpretation: All patients will have baseline scans performed before treatment and according to the randomization group. Treatment and follow-up scans will be approximated at regular intervals of 9-12 weeks or according to local guidelines. The choice of the diagnostic modality does not influence the monitoring intervals or time points. Contrast-enhanced CT of at least the thorax and abdomen will be performed using diagnostic scan quality. Pelvic CT may be added based on clinical need. The scan reports will be made by specialists in radiology with an assessment according to the RECIST 1.1 criteria. FDG-PET/CT will follow standard guidelines from the European Association of Nuclear Medicine. FDG-PET/CT scans will be conducted on EARL2 certified PET scanners, and the quantitative assessment, using the SULpeak value of the hottest metastatic lesion, will based on the EARL2 reconstruction. The CT performed along with the PET scan will be of diagnostic quality and will have contrast enhancement, if not contraindicated. The scans will be assessed by specialists in nuclear medicine according to the suggested PREMIO criteria. According to RECIST 1.1 and PREMIO, disease measurability will be evaluated at the baseline and during follow-up in each study group. In cases of no measurable disease according to the respective criteria applied, the patient's scans will be assessed qualitatively with a parallel response categorization. This categorization slightly differs from the one used in the case of measurable disease, but it still allows for the distinction of progressive disease from all other states. CT and FDG-PET/CT scans will be viewed based on the existing standard software. Viewing of FDG-PET/CT scans will be further supported by software developed as part of the establishment of the PREMIO criteria. Application of the criteria remains a task for radiologists or nuclear medicine specialists. Outcome variables The primary endpoint "Overall survival" will be addressed based on the primary outcome variable "Time from randomization until death". The secondary endpoint "Quality of life" will be addressed by two outcome variables. The first is the overall summary score of the FACT-B, the second the complaints related to the conduct of scans reported by the patients. The secondary endpoint "Exposure to oncologic treatment" will be addressed by the following outcome variables describing different aspects of oncological treatment: Experience of progression Start of a new treatment line because of progression Time to first progression Time from first to second progression Time from second to third progression Experiencing other diagnostic procedures Hospitalization The secondary endpoint "Cost-effectiveness" will be addressed based on relating the outcome variables "Overall survival" and "Quality of Life" to the outcome variable "Costs". These outcome variables correspond to the expected benefits described above. Sample size considerations Sample size considerations are based on using a direct comparison of the survival rates at 42 months. The statistical test finally used will be more powerful due to summarizing the information from all time points and adjustment for prognostic covariates. In the study of Naghavi-Behzad et al. (2022), the survival rate after 42 months was 34% in the CT group and 51% in the FDG-PET/CT group. Due to the introduction of new, more effective treatment lines in the last decade, we expect higher survival rates in this RCT. Sample size calculations are based on the assumption that true survival probabilities will be 39% and 56%, respectively. Under this assumption, we have to include overall 420 patients to reach a power of 87% (based on two-sided testing at the 5% level). According to the timeline of the study, the minimal (planned) follow-up time of the patients will be 36 months, and the maximal follow-up time will be 54 months. In the above calculations, a uniform distribution of the follow-up time was assumed. With respect to the primary outcome (survival), we do not expect drop outs, as we can rely also on national registries. Hence drop-outs are not accounted for in the sample size calculation. Significance level A significance level of 5% (two-sided) will be applied. Exposure to radiation The radiation dose is an issue of consideration. The average radiation dose per patient per scan procedure is estimated, in conventional diagnostic CT, to be 9 mSv and in conventional 18F-FDG-PET/CT to an additional 4 mSv, respectively.
Phase
N/ASpan
213 weeksSponsor
Odense University HospitalOdense
Recruiting
Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
Atrial fibrillation (AF) is the most common arrhythmia in patients with heart failure (HF), with rates ranging between 20-65%, depending on age, severity of HF, subtypes of HF and duration of HF. The two conditions have an intricate and often overlapping pathophysiology, with each condition leading to development of the other, as well as progression of disease. Studies have shown that the presence of AF in HF patients is associated with increased morbidity and mortality, deterioration in HF, exacerbated HF symptoms, and reduced quality of life. The optimal treatment of AF in the presence of HF remains unknown. Currently, there is a pull towards catheter ablation as first-line therapy for AF in HF patients. However, there is no solid scientific evidence to support this approach. Furthermore, it is unknown whether early rhythm control by catheter ablation in HF patients is beneficial. The investigators aim to conduct a pragmatic, randomized clinical trial designed to evaluate the efficacy and safety of early catheter ablation for AF in patients with HF compared with standard treatment. Eligible patients with HF and AF will be prospectively screened from all Danish hospitals and randomized 1:1 to early catheter ablation with pulmonary vein isolation (within 6 weeks) or standard guideline directed treatment for AF. Patients with reversible causes for AF, conditions that preclude the use of catheter ablation or previous catheter ablation for AF will be excluded from the study. Randomization and follow-up will be conducted at six specialized sites in Denmark. There will be one scheduled on-site 12-months follow-up visit after randomization. All clinical follow-up will be conducted at the patient's local hospital, according to standard practice and out of trial setting. Information regarding hospital visits/admissions, events, adverse events, changes in medication, cross-over, heart rhythm and rate, and results of relevant blood-work will be ascertained through systematic patient chart-review at pre-specified time-points. The results from this trial will mold future treatment of AF in HF patients. The investigators hypothesize that early catheter ablation reduces the risk of HF hospitalizations and mortality when compared with standard treatment, thereby significantly improving the clinical prognosis for patients with HF and AF.
Phase
N/ASpan
783 weeksSponsor
Aalborg University HospitalOdense
Recruiting
Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
Please refer to the protocol
Phase
2Span
56 weeksSponsor
Odense University HospitalOdense
Recruiting
Effect Camostat for Kidney Protection in Chronic Kidney Disease
Please refer to the protocol.
Phase
2Span
119 weeksSponsor
Odense University HospitalOdense
Recruiting
Healthy Volunteers
Safety and Performance of UCon Patch Electrode
The overall purpose of this pivotal clinical investigation is to evaluate the UCon device with a Patch Electrode with respect to clinical safety and device performance in a cohort of 180 patients with OAB/BD over a period of 12 weeks. The participants participate in a 12-week intervention period. For weeks 1-6, participants will be randomized (2:1 randomization) to either a treatment group using UCon-Patch with Time Limited stimulation or a sham group using UCon-Sham with sham stimulation. Participants in the treatment group will receive the actual stimulation with the intent of improving their symptoms, whereas those in the sham group will receive sham stimulation for short periods of time believed not to be capable of improving their symptoms. For weeks 7-12 of the intervention periods, the treatment group has the opportunity to add Urge stimulation to the Time Limited stimulation, while the sham group shifts to using UCon-Patch Time Limited stimulation. To assess the safety and performance of the UCon device on equal terms with similar devices in the market, the full intervention period with UCon will be conducted over 12 weeks, evaluating safety aspects of UCon on longer terms and confirming continued effects after 6 weeks in the treatment group. Additional analyses on data related to primary and secondary endpoints with safety and performance data from the 12-week follow-up will also be performed, but the primary analysis will focus on baseline and 6-week follow-up data.
Phase
N/ASpan
157 weeksSponsor
InnoCon MedicalOdense
Recruiting
A Feasibility Study of AMOR; ADHD, Mothers Online Resources
Methods The content of the program has been developed by the Danish ADHD Association (ADHD-foreningen) in collaboration with researchers from Aarhus University and the University of Southern Denmark. This program is specifically designed for pregnant women and new mothers with ADHD as an online group intervention. The online format ensures that transportation time is not a barrier to participation, allowing women from across the country to take part. This is particularly important for inclusion, as the program must be accessible during pregnancy. The program is developed based on the extensive knowledge that the ADHD Association has gained from over 40 years of working with people with ADHD. The content is tailored to the key concerns and challenges related to ADHD in the perinatal period, the period related to pregnancy and the first year postpartum and is based on the general principles of cognitive behavioral therapy. It is also inspired by existing literature, a survey among the female members of the ADHD Association, and interviews with women with ADHD about their experiences with pregnancy and postpartum. Procedure The feasibility trial will be carried out as a mixed-method process evaluation, including both interviews and questionnaire data. The program will proceed over 10 weeks. Questionnaires will be distributed from Research Electronic Data Capture (REDCap) via e-boks at baseline and at 1 week post-program. Interviews will be carried out as focus groups with three participants from each of the three counselling groups and a member of the research team. Eligible participants will be assigned a group, with the first group starting in early 2025. Measurements At baseline, before starting the first session of the program, the women will be asked to fill in questionnaires about their sociodemographic and background information and the following validated and standardized questionnaires; the Adult ADHD Self-Rating Scale (ASRS), the Generalized Anxiety Disorder assessment (GAD7), the Edinburg Postnatal Depression scale (EPDS), the Difficulties in Emotion Regulation Scale (DERS), and the Adult ADHD Quality of Life Measure (AAQoL). One week after the final 10-week program period, the women will be asked to fill in the following questionnaires: The Client Satisfaction Questionnaire (CSQ-8), the Credibility and Expectancy Scale (CEQ), the Negative Effects Questionnaire (NEQ) and again the six questionnaires that were also filled in at baseline. In addition to the quantitative measurements, we will conduct semi-structured interviews with three women from each group one week after the end of the program to assess their subjective perspectives on barriers and facilitators to participate in the program. We will use Clarke and Braun thematic analysis on the interview. Statistical analysis plan Descriptive statistics For participant characteristics, we will summarize baseline sociodemographic and clinical characteristics using means and standard deviations for continuous variables, and frequencies and percentages for categorical variables. For program adherence, we will calculate adherence rates by assessing attendance records for each session. Analyses For the primary outcomes, program satisfaction (CSQ-8), credibility and expectancy (CEQ), and negative effects (NEQ), we will summarize scores using means and standard deviations. For the secondary outcomes, ADHD symptoms (ASRS), perceived stress (PSS), anxiety (GAD-7), depression (EPDS), emotion regulation (DERS-16), and quality of life (AAQoL), we will use paired t-test to compare pre- and post-intervention scores. Power calculation Given the feasibility nature of this study, a formal power calculation is not conducted. However, the sample size of 30 participants, divided into three groups, is deemed sufficient to provide preliminary insights into program feasibility, adherence, and potential impacts on clinical outcomes. Processing of personal data in the project All personal data will be processed in compliance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act. Any personally sensitive information is processed by OPEN (Open, Patient data Explorative Network) in personally identifiable form for as long as it is necessary for the research purpose. The storages of information are in accordance with responsible research practice and in relation to general data protection regulation. Individual participants will not be identifiable in published data, as the information of trial participants is anonymized, and individuals cannot be recognized. We will prioritize the protection of participants privacy and adhere to ethical guidelines. Anonymization involves removing personal identification details to prevent the disclosure of individual participants identities in published results and by reporting results that are based on at least 5 individuals. When the data is no longer necessary for the research project, it will be sent to the national archive and stored for five years. The project is registered at the University of Southern Denmark (journal nr: 12.303 - HELP - Mental health in pregnant women and new mothers with ADHD). Economy The initiative for this trial was taken by associate professor Kathrine Bang Madsen. Funding is provided by Sygeforsikring "danmark" (Journalnr. 2021-0139 HELP - Mental health in pregnant women and new mothers with ADHD) as part of a larger project called HELP with an amount of DKK 5 mio, of which DKK 1.5 mio covers the development and evaluation of the counselling program. The financial support cover costs related to program development (to ADHD-foreningen), participant recruitment, and data analysis, and is administered by the University of Southern Denmark (SDU). The funding body has had no role in the study design, data collection, data analysis, data interpretation, or manuscript writing. Recruitment and informed consent The Danish ADHD Association will advertise for the counselling program and the research project on their homepage and social media platforms. Those interested in participating can sign up by providing their email address via the homepage. They will then receive an email with details about the research project and are encouraged to reply with their phone number. The instructor of the program from the Danish ADHD Association will contact the participant by phone and screen the participant based on the eligibility criteria and provide the participant with information about the study. The verbal information given by phone includes the purpose and method of the program and the feasibility study, the voluntary nature of participation, that neither participation or non-participation will have an influence on other treatment options available to the individual, and the right to a consideration period (one week). The consent process is a dialogue, and the individual participant can ask questions about the program and study. During the phone conversation, participants will be asked about their pregnancy status, since they will need to be pregnant. They are asked to share information about their ADHD diagnosis, including when they were diagnosed. Additionally, we will collect information about their living situation, such as whether they live with the child's father, their employment status, and similar details. If the participant meets the inclusion and exclusion criteria and decides to participate in the study, she will receive written information about the study and a consent form through e-mail via REDCap (Research Electronic Data Capture), which can be signed electronically. From the day of receiving the written information, the participant will have one week to consider participating. After signing, the participant will receive a copy of the consent form. The consent form will be stored in REDCap. Ethics The trial poses minimal risks and offers potential therapeutic benefits that justify its conduct. The intervention is expected to significantly improve participants well-being and quality of life, benefiting both mother and baby. The counselling program AMOR is the first program to address the needs of pregnant women and new mothers. However, based on experiences with similar online programs for adults with ADHD (outside the perinatal period), the program is expected to enhance understanding of ADHD during pregnancy and childbirth, providing practical strategies for managing daily life during pregnancy and as a new parent. Other studies have not reported on negative effects, however, during each session, participants will be informed by the instructor to contact their general practitioner, midwife, or health nurse if they need more assistance than the program can provide. In addition, we will assess any potential negative effects after the end of the program. Participants will be informed of their rights and the compensation scheme for any injury related to the intervention. Should participants exhibit scores exceeding 15 on the Generalized Anxiety Disorder-7 (GAD-7) scale and 18 on the Edinburgh Postnatal Depression Scale (EPDS) at baseline, they will be contacted by phone by one of the responsible investigators and encouraged to consult with their healthcare provider, such as their doctor or midwife and they will be informed that they are not eligible to participate in this study.
Phase
N/ASpan
49 weeksSponsor
University of Southern DenmarkOdense
Recruiting
Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents
Phase
4Span
320 weeksSponsor
Odense University HospitalOdense
Recruiting
SHORT-term Effects of GLucagon-like Peptide One on BonE
Phase
N/ASpan
52 weeksSponsor
Odense University HospitalOdense
Recruiting
Healthy Volunteers
Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention
Phase
N/ASpan
398 weeksSponsor
Odense University HospitalOdense
Recruiting