ANZCTR search results

This study is investigating the usefulness of a new type of positron emission tomography (PET) scan, targeting “prostate specific membrane antigen” (PSMA), in patients being treated for metastatic clear-cell renal cell carcinoma. Who is it for? You may be eligible for this study if you are 18 years of age or older and have metastatic clear-cell renal cell carcinoma that has been previously treated with at least one anti-VEGF TKI and can tolerate PET scan procedures. Study details Participants will undergo usual standard of care treatment including standard CT diagnostic imaging and blood tests, which all treatment decisions will be based upon. They will also undergo a PSMA-PET scan at 3 timepoints; baseline, 4 weeks and 12 weeks, and these results will purely be for research use. The additional PSMA-PET scans are anticipated to take approx 30 mins and will involve injection of a small dose of radioactive tracer into one of your veins. Information from this study will be used to better understand whether such PSMA-PET scans are useful for visualising patients’ tumours after they have been treated.

Bulimia Nervosa (BN) and Posttraumatic Stress Disorder (PTSD) commonly co-occur, and cause great distress to sufferers. One suggestion for the lack of treatment success for patients with this co-morbidity is the lack of attention paid to the maintaining factors, such as PTSD symptoms. Thus, this study will address a treatment gap by focusing upon whether addressing the traumatic memories of patients with BN/PTSD improves eating disorder and trauma related outcomes. The data gained from this study will facilitate modifications to the newly developed therapy, Memory Reconsolidation Therapy, which may improve the effectiveness of the treatment for patients. The information may also be used to inform pilot randomised controlled trials, or studies in populations with other disordered eating behaviour (e.g., binge eating disorder). This is a case series trial, which will recruit approximately 6 participants with BN and PTSD. Questionnaires will be administered prior to treatment, immediately after treatment, and three months after treatment concludes. Progress questionnaires will be administered every session. The treatment will consist of four phases, including: intake and assessment; brief psychoeducation on emotions; memory reconsolidation therapy with imagery rescripting; and termination of the therapy. Primary Hypotheses • It is proposed that adult participants diagnosed with Bulimia Nervosa BN and PTSD will significantly improve in eating disorder symptoms, as measured by the EDE-Q, post-treatment compared to pre-treatment. This improvement will be maintained three months post-treatment. • It is proposed that adult participants diagnosed with BN and PTSD will significantly decrease scores on the PCL-5 over 12-16 sessions of treatment. This improvement will be maintained three months post-treatment. Secondary Hypotheses • It is proposed that adult participants diagnosed with BN and PTSD will report significantly decreased negative beliefs about emotions, as measured by the BAEF, post-treatment compared to pre-treatment. This improvement will be maintained three months post-treatment. • It is proposed that adult participants diagnosed with BN and PTSD will report significantly decreased posttraumatic cognitions, as measured by the PTCI, post-treatment compared to pre-treatment. This improvement will be maintained three months post-treatment. • It is proposed that the self-reported frequency of objective binge eating episodes, self-induced vomiting, laxative misuse, and excessive exercise will decrease over the course of treatment.

Each year, researchers and doctors work to find better tests, treatments, and services for children. They often use questionnaires that ask about a child’s general health (also called ‘health related quality of life’ (HRQoL)) to understand how these tests, treatments and services improve children’s lives. However, sometimes this can be hard as there is a lack of HRQoL questionnaires available for children aged 2-4 years old as well as a lack of evidence for how these questionnaires perform in children of this age group. This study has adapted a commonly used questionnaire for slightly older children (EQ-5D-Y) for children aged 2-4 years. We will compare how this new adapted questionnaire performs compared to the other currently available HRQoL questionnaires for children in this age group. This will involve collecting an initial and follow-up survey from participants. The follow-up survey will be a simplified version of the initial survey that will be sent 2-8 weeks after completion of the first survey. The performance of the new adapted questionnaire will be analysed and compared to the performance of other HRQoL questionnaires for children aged 2-4 years. We will also look at how the performance compares by child age and disease group. We plan collect data on 400 Australian children aged 2-4 years (from children who are well through to those that are very sick). The primary objective of the study is to understand how well the new adapted questionnaire (adapted version of the EQ-5D-Y) performs compared to other currently available child HRQoL questionnaires for children aged 2-4 years (i.e. consistency, acceptability, feasibility, reliability, responsiveness and validity). Another objective of the study is to provide a validated EQ-5D-Y version for young children that is ‘fit for purpose’ in judging the effectiveness and cost effectiveness of child interventions.

The primary objective of this study is to evaluate the feasibility of conducting a trial comparing the efficacy of a multifaceted, non-surgical intervention (including self-management advice, footwear, foot orthoses and foot exercises) versus usual care (self-management advice) for reducing pain associated with hallux valgus (also known as 'bunions') in women aged 40 years and over. Feasibility will be assessed using measures of demand, acceptability, adherence, adverse events and drop-out rate. The secondary objective is to obtain statistical parameters to inform the main trial sample size calculation and providing signal of efficacy to justify the future main trial.

This study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of an experimental new drug, ANPA-0073 being developed for the treatment of Pulmonary arterial hypertension

A hernia is a bulge of bowel or other abdominal organs through a weakness in the abdominal wall muscles. A ventral hernia is a type of hernia through the abdominal wall which appears in the middle of your abdomen. It may appear as a lump or bulge, and over time may increase in size and cause pain. This type of hernia can be caused by previous abdominal surgery, weak abdominal muscles, heavy lifting, pregnancy and other causes of weakness of the abdominal wall. When required, a hernia may be repaired surgically using either keyhole surgery (laparoscopic surgery) or a larger incision (open surgery). The goal of surgery is to repair the weakness in the abdominal wall to prevent the abdominal contents protruding through and causing a bulge and pain, and preventing strangulation of those abdominal contents. As part of the procedure, it is standard practice to place a supporting sheet of mesh to act as a reinforcing patch and to help strengthen the abdominal wall and keep the abdominal contents in place. Surgeons can use either sewing stitches (sutures) or tacks (small metallic fixtures) to secure this patch in place. Both of these methods are routinely used in this type of operation. The purpose of this study is to to see if suture repain is less painful than the tack repair and improve mobility for patients following this procedure. We will do this by comparing the two different surgical techniques used to secure the mesh in place.

Approximately 4.1 million Australian adults suffer from hypertension, which was estimated to cause 26,000 deaths in Australia in 2017. Excess dietary salt consumption is a leading cause of high blood pressure, and dietary guidelines specifically recommend the avoidance of foods high in salt for blood pressure lowering. Yet, current individual-based education and clinical counselling to reduce salt intakes has shown limited effectiveness, is resource intensive, costly, and has limited reach. Hypertensive patients in Australia currently consume on average ~10g salt per day, nearly twice the World Health Organisation recommended maximum; with most (~80%) dietary salt derived from eating packaged and processed foods. Thus, innovative strategies are urgently needed to help hypertensive patients reduce their dietary salt intake. The overall goal of this research is to determine the effectiveness of a novel, scalable, and sustainable salt reduction intervention (online grocery shopping, OGS) for lowering blood pressure (BP) amongst patients with hypertension. We will do this by conducting a large-scale randomised controlled trial (RCT) using an online grocery shopping intervention designed specifically for Woolworths, Australia’s largest online grocery retailer. The OGS will be provided to the study participants as a web-browser application, such that every time participants purchase groceries online, OGS will provide immediate on-screen, interpretive (i.e. colour-coded symbol) nutrition information and specific suggestions for lower salt alternatives. The personalised approach – consumers can maintain their usual dietary patterns and are guided to choose similar, but lower-salt alternative products – offers flexibility and caters to personal preferences. If this intervention demonstrates even a 2 mmHg BP lowering effect, then it would be meaningful because 2 mmHg lower BP translates into an approximately 10% reduction in premature cardiovascular disease (CVD) amongst hypertensive patients. There is currently no other platform that could improve dietary behaviours more rapidly to reduce BP amongst Australians. The OGS online grocery shopping intervention has the potential to have a major effect on BP control and prevention of CVD in Australia and globally.

68Ga NODAGA GSAO is a new radioactive compound that when injected allows a different type of PET scan to be performed to directly image dead and dying cells. This study aims to determine how 68Ga GSAO is taken up by both cancer and non-cancer cells in a small group of cancer patients. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a histologically or cytologically confirmed solid cancer with at least one measurable lesion >2 cm and you meet pre-specified requirements for liver and renal function. Please note that patients with primary or metastatic brain or spinal cancer will not be eligible for this study. Study details Participants who choose to enrol in this study will be injected with 68Ga NODAGA GSAO and following this they will undergo a total of eight PET imaging scans (during which they will be required to lie still on a scanning bed breathing normally). The first six scans will be performed one after the other (total duration of approximately 90 minutes). Participants will then have a break and then undergo two further scans each taking approximately 30 to 40 minutes (with a break in between). Participants will also have blood and urine samples collected to determine the amount of 68Ga NODAGA GSAO in blood and excreted in urine. The total duration of the study will be approximately five hours. Patients will also be followed up for 7 days after 68Ga NODAGA GSAO PET scanning to determine if they have experienced any side effects from the injection. It is hoped this research may be used to improve health outcomes for future cancer patients by investigating the safety and usefulness of the 68Ga NODAGA GSAO PET scan to image cancer cell death as a way of determining cancer treatment response earlier and more accurately than currently available imaging methods.

Aboriginal and Torres Strait Islander people residing in remote communities experience the highest reported rates of food insecurity in Australia. We will test an intervention to improve diet quality for women and children, by making healthy food and drinks more affordable. Price discounts on a range of healthy food and drinks will be accessible to participants via loyalty cards, with discounts being advertised in store and locations frequented by the participant group. This research will enhance our understanding of the impact of price discounts on diet quality. We hypothesise that participants in intervention vs. control communities will have a greater increase in dietary quality from baseline.

The PARAGON-II clinical trial seeks to improve outcomes for post-menopausal women with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. The study aims to investigate if the combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates, as compared to historical controls from the PARAGON trial, in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated. Who is it for? You may be eligible for this study if you are aged 18 or older, with advanced (recurrent and/or metastatic) gynaecological cancers, that are hormone-receptor positive. Study details Participants will be allocated to one of the two treatment groups based on the PIK3CA mutation status, then followed-up to see if outcomes are improved and what side-effects occur. Clinical assessment, imaging, blood tests will be performed. CA125 tumour and Patient Reported Outcomes will be also be assessed during the study. It is hoped that combination treatments of letrozole plus alpelisib, and letrozole plus ribociclib, will lead to an increase in overall response rates in HR+ advanced gynaecological cancers that are either PIK3CA-mutated or PIK3CA non-mutated.