ANZCTR search results

This is a prospective single site study evaluating the additive value of a diagnostic test (Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET)) in addition to and in combination with the current gold-standard reference mpMRI scan in men who have undergone Focal therapy for prostate cancer with Irreversible Electroporation (IRE) procedure. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with prostate cancer and you are scheduled to undergo a primary focal IRE (Nanoknife®) procedure as part of your cancer treatment. You should also have undergone both a PSMA PET/CT scan and an mpMRI scan prior to any surgical treatment as these images will be used for comparisons. Study details All participants who choose to enrol in this study will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 12 months of undergoing the IRE procedure to treat their cancer. The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and a biopsy (tissue sample) of any remaining tissue. It is hoped this research will determine whether adding a PSMA PET/CT scan to the current standard of care mpMRI scan is able to better detect residual/recurrent clinically significant prostate cancer. If the PSMA PET/CT scan is found to be a helpful addition to the current mpMRI scan, or is found to be more accurate in detecting prostate cancer than the mpMRI scan, a larger trial involving a greater number of patients with prostate cancer may be undertaken.

Multivitamin supplements have been reported to be the most commonly taken dietary supplements in Australia (Australian Bureau of Statistics., (2020-21). Supplement users were also found to have higher intakes, in their diet (from food only), of fibre and more vitamins and minerals (except zinc and vitamin B12) than non-supplement users. Additionally, intakes of all vitamins and minerals were higher when the contribution from supplements was added into overall intakes. This demonstrates the potential benefits of multivitamins to supplement overall nutrient levels, with the aim of supporting overall health and wellbeing (Burnett et al., 2017). To best support the health and wellbeing of Australians, Swisse conducted a targeted reformulation of their Ultivite Multivitamins to ensure that they were meeting the present needs of Australian adults as evidenced in the population data. This real-world direct-to-participant study aims to understand healthy volunteers’ perspectives and experiences whilst taking the Swisse Ultivite Multivitamin products. Presently, the rigorous clinical trials and scientific evidence that is used to support relevant indications, in line with TGA requirements and approval, does not reflect a real-world environment. Research of this nature is not intended for regulatory submission/dossier nor for pack claims, but rather seeks to explore typical product use and understanding of participant perspective in an environment that is not tightly controlled. In order to replicate a real-world setting, the use of randomization, blinding and placebo is not included, and the limitations of the study design have been greatly considered. Overall, the study aims to generate complementary evidence on user experiences for Swisse Ultivite Multivitamins for the purpose of publication and potential use in advertising claims.

This is an open-label pilot study to assess XW10508 MR safety, tolerability and efficacy in patients with Major Depressive Disorder. The hypothesis is oral XW10508 MR tablets will rapidly improve and maintain the treatment of depression symptoms without significant adverse effects and with good patient tolerability.

Addictive eating is a behaviour that contributes to excess energy intake (calories) and is associated with overweight and obesity trajectories, a major health problem affecting over 60% of young adult Australians and is a key risk factor for cardiovascular disease (CVD). Moreover, addictive eating is associated with depression and anxiety, which is the leading cause of disability and premature death in Australia. In these instances, food may be used to reinforce comfort and/or to stabilise mood. Approximately one in five individuals with CVD suffer from depression, while one in four suffer from anxiety. Our research illustrates that these comorbidities (obesity and mental health) cluster together, which if better understood, could be targeted more effectively through better identification and assessment to trial tailored novel interventions for addictive eating. Current guidelines for obesity and CVD focus on reducing energy and saturated/trans-fat, rather than eating behaviours. Despite the extent of obesity and CVD, interventions to treat CVD risk factors are only moderately effective in the short-term. There is a need for effective behavioural approaches for addictive eating for CVD prevention. The proposal builds upon previous research (ACTRN12619001540101, ACTRN12621001079831) to determine the feasibility of a personality-based intervention for young adults with addictive eating, in a 3-month trial. It will be delivered using technologies, including telehealth, a website, text messages and email. This approach means the program can be delivered anywhere in Australia to individuals in any location. This trial will enable a better understanding of the relationship between CVD and problematic eating behaviours, assist the generation of new treatment principles and enhancement of identification and assessment of at-risk individuals and transitioning them to the right intervention for their condition.

This study aims to investigate the potential of a new PET imaging tracer, [68Ga]Ga-FAPI-04 (Fibroblast Activation Protein Inhibitor), for imaging pancreatic cancer and malignant pleural mesothelioma (lung cancer) compared to the current standard imaging tracer [18F]FDG. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with either pancreatic cancer which is locally advanced or recurrent/progressive or malignant pleural mesothelioma and have been referred by your treating doctor to have a fluorodeoxyglucose (FDG)-positron emission tomography (PET) scan (or FDG PET scan). Study details All participants who choose to enrol in this study will be asked to undergo one PET scan with the [68Ga]Ga-FAPI tracer. This involves one additional visit to hospital within one week of your FDG PET scan. At this visit, a needle is inserted into a hand or arm vein and a small amount of the radioactive [68Ga]Ga-FAPI is injected. Participants will rest for up to 3 hours while the [68Ga]Ga-FAPI travels through the blood stream and is taken up by pancreatic cancer cells or mesothelioma cells before being positioned on the bed of the PET scanner. The time in the scanner is around 30 minutes and the total time required for this visit will be up to 4 hours. This additional PET scan is for research only and will not be used to change your treatment. Over the next 12 months, your medical records will be accessed to follow up your clinical treatment and any other imaging performed. This will not involve any additional appointments for you. It is hoped this pilot study will confirm that advanced pancreatic cancer and mesothelioma cancer cells express Fibroblast Activation (FA-protein) on the cell surface and can be imaged with [68Ga]Ga-FAPI PET imaging. If so, future research will examine using the FAPI agent with a different radioactive tag which could kill the cancer cells instead of imaging them.

This study aims to assess a new cancer drug, GRWD5769, in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have a cytologically or histologically confirmed locally advanced or metastatic solid malignancy not considered for further treatment, and have progressive disease after treatment with other agents. Study details All participants will receive treatment with GRWD5769 and cemiplimab-rwlc 350 mg. After an initial single dose, GRWD5769 will be administered as an oral capsule throughout the study twice a day. cemiplimab-rwlc will be administered by intravenous infusion of 350mg over 30 minutes once every 3 weeks. Treatment will continue until participants withdraw from the study or their disease progresses. During the treatment period, participants will undergo study visit for screening and an initial confinement period commencing up to 2 days prior to the first dose until Day 2 of Cycle 1 (minimum of 2 nights). Further confinement periods are required for assessments on Day 14 & 15 of Cycle 1. Participants will also undergo imaging every 56 days for the duration of the study to assess for their response to treatment. It is hoped that this study will show that GRWD5769 is safe, tolerable, and effective for the treatment of advanced solid cancers. This study will also help to define the dose of GRWD5769 that may be used for treatment of similar individuals in future.

Automated insulin delivery (artificial pancreas systems) can help to improve management of glucose levels in people living with type 1 diabetes while at the same time reducing the heavy intellectual and psychological burden of care. However, the success of closed-loop/artificial pancreas devices moving forward relies upon their ease of use and ability to reduce and relieve the burden of living with type 1 diabetes. Current commercially available automated insulin delivery devices represent hybrid closed loop (HCL) systems requiring the user to initiate boluses of insulin to address meal-time insulin requirements. Eliminating a requirement for the user to bolus for meals, without compromising glucose control, would substantially reduce the burden of care on people living with type 1 diabetes. The Medtronic MinimedTM NMX-AID system is a new-generation closed loop system (artificial pancreas) similar to an existing, commercially available Medtronic insulin pump, the MiniMedTM 780G Pump, and has the capability to operate in Manual Mode (also referred to as open loop) or with the SmartGuard feature active (also referred to as closed loop). However, the NMX-AID system differs from the Minimed 780G Pump as it contains modifications to the closed loop algorithm, including the addition of a Pump Start feature that enables the user to skip the 48-hour warm-up to enter SmartGuard and also allows automatic delivery of meal boluses without user input or acknowledgement. These new advances have significant potential to improve the experience of using closed-loop technology. The aim of this study is to demonstrate feasibility of the device, and to generate initial data to evaluate safety, user acceptance and system efficacy of the Medtronic Minimed NMX-AID system in adults with type 1 diabetes. We believe that the Medtronic Minimed NMX-AID system will be feasible and safely improve user satisfaction in people with type 1 diabetes without sacrifices in glucose control compared with insulin delivery with the MiniMed 780G system.

Our previous research found that an ultra-brief online treatment was effective for managing depression and anxiety symptoms. This research trial is testing how quickly people with a diagnosed depressive or anxiety disorder benefit from an ultra-brief treatment. People will be randomly allocated to receive access immediately or after a 4-month waiting period. Questionnaires will be administered every 2 weeks for 4 months. The primary endpoint is Week 17 and we expect that the treatment will result in larger reductions in depression and anxiety compared to the control.

This trial will evaluate a highly accessible and ultra-brief online psychological treatment for women with perinatal depression or anxiety. The treatment involves online materials and optional support from a psychologist. We will evaluate how helpful the treatment has been 2 weeks and then 4 weeks after baseline. All participants will complete questionnaires at baseline, Week 3, and Week 5. We hypothesise that the treatment will lead to reductions in depression and anxiety.

Recent research suggests that our circadian rhythm plays a very important role in how we develop and how our immune system works. The CIRCA DIEM Study (ACTRN12618000371291) is randomising hospitalised premature infants born before 32 weeks gestation to be standard routine care or to be cycled between an artificial night-time from 8 pm to 6 am (using eye masks to block out light and ear plugs to reduce noise) and then to be exposed to an artificial daytime from 6 am to 8 pm (removal of eye masks and ear plugs and light levels from 300-600 lux (similar to low-level office lighting). The intervention continues until babies are discharged home to a normal day/night environment. As part of the CIRCA DIEM trial, we are inviting participating families to enrol their baby into an Infection and Immunology substudy. The main aim of the CIRCA DIEM Infection and Immunology Sub-Study is to find out whether the timing of the development of a circadian rhythm influences the likelihood of premature babies developing infections that require hospitalisation over the first 2 years of life. Babies enrolled in the CIRCA DIEM main study whose parents agree to their participation in the Infection and Immunology Substudy will be followed-up after discharge home using a mobile app to track infant well-being, presence of symptoms of infection, visits to health care providers and hospitalisations. Some infants will also have some biological samples collected to help us understand the mechanism of any differences that are evident between the intervention and control groups with respect to hospitalisations for infections and other secondary substudy outcomes.