ANZCTR search results

This study is looking at a new way of detecting the spread of pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have biopsy proven pancreatic adenocarcinoma. The tumour may be operable, locally advanced or metastatic. Any prior treatment is allowed. Study details All participants in this study will undergo a single 68Ga-CPCR4-2 PET/CT at the Herston Imaging Research facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into your vein and inject a radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid-thigh. The scan time for the 68Ga-Pentixafor PET/CT will be approximately 35 - 40 minutes. An 18F-FDGPET/CT scan will also be conducted at HIRF for patients identified to have metastatic disease at diagnosis. You will be asked to fast for 6 hours prior to the scan. A qualified Nuclear Medicine Technologist will insert a tube into your vein and inject radioactive substance called FDG. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid-thigh. The scan time for the FDG-PET/CT will be approximately 30 minutes. Patients with localised pancreatic cancer at diagnosis will undergo standard of care FDG-PET/CT scan performed at the Royal Brisbane and Women’s Hospital Department of Nuclear Medicine. We will monitor all participants for adverse events. Before, during and for 30 days after your PET/CT Scans or until treatment begins you will be asked to report any side effects to your doctor. It is hoped that this study will help us to achieve more accurate staging at diagnosis to guide future treatment decisions.

What is this study for? This study aims to assess the psychological and behavioral outcomes associated with offering women their personal polygenic risk score for breast cancer risk. The study will include women who opt to receive their results as well, as those who decline this offer. Who is it for? You may be eligible to participate in this trial if you are a woman aged 18 or over who has already enrolled in the 'Variants in Practice’ study (ViP) in whom known breast cancer predisposition genes have been excluded as the cause of your personal and/or familial breast cancer risk. Study details: Participants enrolled in this trial will have a personal polygenic risk score (PRS). Individual PRS result has been calculated as part of the parent study “Variants in Practice”. Participants who opt to receive the results will then attend a one hour face-to-face session with a clinical geneticist or genetic counsellor who has received training in delivering these results. During this session, the risk score will be discussed as well as any preventative strategies which may be considered. Participants can also opt to not receive their results, in which case they will not receive this face-to-face session. All participants will be asked to complete a number of questionnaires assessing the psychological effects of receiving or not receiving their risk score. It is hoped that the findings from this trial will help to develop a model of care offering polygenic breast cancer risk testing, in which results are provided to participants without causing negative psychological effects such as breast cancer anxiety and depression.

This study aims to evaluate the performance of 68Ga-Pentixafor positron emission tomography (PET) imaging in a cohort of newly diagnosed and relapsed myeloma patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have newly diagnosed or relapsed multiple myeloma, defined by >10% plasma cells on bone marrow biopsy or biopsy-proven plasmacytoma. Study details All participants in this study will undergo pentixafor-PET imaging and simultaneous whole-body magnetic resonance imaging (MRI) in a single sitting. The PET scan is the investigational intervention while the MRI scan is the internal control/gold standard. A qualified Nuclear Medicine Technologist will insert a tube into a vein and give you an injection of a new radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid thigh. The scan time for the 68Ga-Pentixafor PET/MRI is approximately 1hour. After the examination is completed, you will be able to eat and drink normally. Participants who have a positive PET will then be asked to undergo a second PET/MRI at the completion of their therapy. The scans will be interpreted using pre-specified criteria by investigators in the Department of Medical Imaging and Department of Nuclear Medicine at the Royal Brisbane Hospital. We will be examining a) the accuracy of pentixafor-PET compared with whole-body MRI for diagnosing myeloma bone lesions, b) the relationship between PET positivity and conventional disease prognostic markers, and c) the correlation between PET response and conventional biochemical response markers. It is hoped that PET imaging may offer complementary information about disease staging and prognosis, as seen in many other cancers including lymphoma and melanoma.

This study aims to evaluate the use of an investigative imaging technique, known as CXCR4 positron emission tomography (PET), for disease staging in patients with resectable mucosal head and neck squamous cell carcinoma (HNSCC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have biopsy proven mucosal head and neck SCC suitable for upfront surgery with planned neck dissection. Study details Prior to resection and in addition to our usual standard of care assessments, all participants in this study will be imaged with PET/CT and PET/MRI with a CXCR4 tracer (68Ga-CPCR4-2) and have blood and saliva collected.

A single centre double blinded randomised control trial to determine if surgical TAP blocks provide any additional post-operative analgesic benefit compared with conventional oral analgesia for caesarean sections under spinal anaesthesia with intrathecal fentanyl. 100 term pregnant women undergoing elective caesarean delivery with spinal anaesthesia (2.2mL 0.5% hyperbaric bupivacaine and 15mcg fentanyl) are to be enrolled. Patients will be randomly allocated to one of two groups of 50: they will either receive a surgical TAP block or no TAP block. In the relevant group the TAP block will be performed by the surgeon after closure of the uterus. Patient blinding will be maintained by use of the standard surgical drapes. Data collection will be carried out by the acute pain service (APS) who will also be blinded when doing follow-up assessments of pain (visual analogue 0-100mm) scores (VAS) at 2, 6, 24 and 48 hours and cumulative oxycodone use at 2, 6, 24 and 48 hours. The primary outcome will be the visual analogue scale (VAS) pain score (0-100mm) at six (6) hours post-operatively. Secondary outcomes will be: 1. Rest and dynamic visual analogue scale (VAS) pain scores (0-100mm) at 2, 6, 24 and 48 hours post-operatively. 2. Oxycodone IR use at 2, 6, 24, and 48 hours 3. Patient satisfaction scores at 24 and 48 hours (10: completely satisfied, 1: completely dissatisfied). 4. Opioid-related adverse effects including sedation, nausea, vomiting, itch and constipation over 48 hours. Sedation (assessed by the Ramsay Sedation score 1-6). The remaining side effects are graded 0-3 where 0 is none, 1 is mild with no treatment required, 2 is moderate and treatment required and helpful and 3 is severe where treatment is required and not helpful. Constipation is assessed at 48 hours only. 5. Incidence of symptoms of local anaesthetic toxicity (perioral tingling, metallic taste, tinnitus, visual disturbance, slurred speech) at 2 hours. Hypotheses 1. Surgical TAP blocks significantly reduce pain post LSCS under spinal anaesthesia as defined by reduced visual analogue scale (VAS) pain scores and oxycodone use at 2-48 hours and greater patient satisfaction scores compared to having only conventional analgesia. 2. Opioid-related adverse effects including post-operative nausea and vomiting (PONV), pruritus, sedation, constipation) by 48 hours post-operatively are reduced in the surgical TAP block groups compared to those receiving only standard care.

This feasibility trial will evaluate the provision of pre-operative carbohydrate drinks in the acute hip fracture setting to inform feasible and clinically relevant reserach protocol to enable a larger efficacy study to answer the research question.

Bladder infections (urinary tract infections or UTI) are amongst the most common infections in women. It is estimated that almost 50% of women will experience at least one episode of UTI in their life time and almost 44% will experience a recurrence within 6 months. These infections can be very troublesome and cause issues like burning sensation when urinating or going very frequently to pass urine, lower abdominal pain, nausea and vomiting, tiredness, days lost from work and sometimes admission to hospitals. While treatments are available to treat these infections, some women will experience several UTI during a year. These women may benefit from preventive treatments. In this study, we are planning to use Methenamine Hippurate or Hiprex which breaks down to a specific chemical in the bladder which can stop the bacteria growing in the bladder; it is not an antibiotic. The rationale in using this medication is that to date there has been no bacterial resistance reported to Hiprex and generally it is a well-tolerated medication with a low side effect profile. In this study, we will compare Hiprex to nitrofurantoin, an antibiotic used for many years to treat and prevent UTI. While effective, nitrofurantoin has the same implications as other antibiotics when used long-term which are resistance and side effects.

This is a prospective observational study looking at bone health in transgender individuals. The purpose of this study is to investigate the changes that occur during cross sex hormone therapy for gender dysphoria, in particular changes to the architecture of bones but also to muscle mass, fat mass, cardiovascular risk factors and quality of life. We will recruit participants just about to start on hormone therapy (i.e. have not previously taken gender hormones in the past) . We plan to review participants 5 times over a 2 year period and will be using DXA/body composition scans as well as a specialised bone CT scan. We will also be performing blood tests and quality of life surveys.

Extremely premature infants do not tolerate enteral feeds well and are routinely tube fed. Our pilot trial suggests that regular smell and taste of milk with tube feeds may lead to better milk tolerance in very preterm infants, but interestingly may also increase weight z-scores at discharge, an outcome potentially relatedto better head growth and later neurodevelopmental outcomes.

The purpose of the proposed project is to examine the acceptability, efficacy and feasibility of a low-intensity CBT-based self-management program, the Wellbeing Neuro Course to support the emotional and cognitive health of adults with neurological conditions. The proposed trial employs a single-group open-trial design (n = 100) and participants will be given access to a modified version of an established self-management Course for managing depression, anxiety and disability associated with chronic conditions (the Chronic Conditions Course). The Course contains a 6-lesson 10-week internet delivered program. Participants will have brief weekly contact with a clinical psychologist as they work through the Course. A single-group open-trial feasibility design will be employed; all participants are provided full and immediate access to the Wellbeing Neuro Course and are asked to complete standardised questionnaires at 3 main time points: Pre-treatment, post-treatment and 3-month follow-up.