ANZCTR search results

Constipation is a common problem in people with end stage kidney failure. Treatment of this condition with a high fibre diet and adequate fluid is not possible in this group of people because they need to follow a specialized diet and restrict their fluid intake. The aim of this study is to determine if a non drug treatment in the form of 40g of almonds daily for 4 weeks will help improve the symptoms of constipation. Other outcomes such as improvements to the level of inflammation, dietary intake, memory, gut bacteria and quality of life will also be investigated.

This study aims to assess the effect of nicotinamide (vitamin B3) on nonmelanoma skin cancer incidence in renal, hepatic, heart and lung transplant recipients. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have had a transplant more than 12 months ago. You should be experiencing current immune suppression and have a past history of at least two confirmed nonmelanoma skin cancers within the past 5 years. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take two 500mg nicotinamide (vitamin B3) tablets daily for 12 months, whilst those in the other group will take two placebo (inactive) tablets daily instead. Participants will not know which group they are in until the end of the trial. Participants will be regularly assessed over the treatment period to determine the efficacy of nicotinamide in preventing nonmelanoma skin cancers and the safety of this treatment in transplant recipients.

This pilot study will be the first to report on the response of myopic (short-sighted) children living in Australia to low dose atropine treatment. It will also examine outdoor/physical activity levels to inform guidelines that balance minimizing the long term effects of myopia (short-sightedness) versus the risks of increased UV exposure. The aim of this study is to test whether a very dilute (0.01%) solution of muscle relaxing mediation (Atropine) given as a single daily eye drop, can slow the progress of myopia. The treatment part of the study will run for 2 years.

This study will evaluate the use of PET/CT and PET/MRI imaging for head and neck cancer patients receiving definitive radiation or chemoradiation treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are receiving definitive radiotherapy or chemoradiation for head and neck cancer at the Royal Brisbane and Women’s Hospital. Study details All participants in this study will undergo an additional imaging session at the Herston Imaging Research Facility (HIRF). During the additional imaging session participants will undergo a 18-FDG PET/CT and 18-FDG PET/MRI. You will be asked to fast for up to 6 hours prior to the scan session. A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called FDG. If you are having the PET/MRI first then the scan will start immediately during the period known as the uptake time. You will be positioned in a way that closely matches your radiation therapy treatment position. The scan involves lying flat with knees and neck supported. The scan time for the FDG PET/MRI is approximately 1 hour. After the examination is completed, you will be asked to empty your bladder and move to the PET/CT scanner where the scan will commence. The exam will take approximately 30 minutes. After the examination is completed, you will be able to eat and drink normally. If you are having the PET/CT scan first then you will rest for 1 hour during the uptake time, before emptying your bladder and proceeding to have your PET/CT scan which will last approximately 30 minutes. You will then be moved to the PET/MRI scanner and the scan will commence, lasting approximately 1 hour. After completing both scans you will be able to eat and drink normally. Gross tumour volumes derived from each of the scans will be compared, as will the radiation dose. It is hoped that the new scans will improve our ability to localise cancer more accurately than our current methods, for planning radiation treatment.

This study will compare the accuracy of an investigative imaging technique (known as 68Ga-CPCR4-2 (68Ga-Pentixafor) PET/CT imaging) with conventional staging (contrast enhanced Pelvic MRI and CT chest, abdomen and pelvis) at initial diagnosis of rectal 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, newly diagnosed rectal adenocarcinoma (of any subtype). Study details All participants in this study will undergo a 68Ga-CPCR4-2 (68Ga-Pentixafor) PET scan together with a contemporaneous, non contrast, low dose CT for anatomical correlation, in one session, at the Herston Imaging Research facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of 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 45 minutes. We will monitor all participants for adverse events for 30 days after the PET scan or until the time of treatment initiation whichever comes first. We will also measure the level of tracer uptake by the cancer . If results of this study are promising, we hope to further explore the impact of the PET tracer on management decisions, diagnostic accuracy, as well as the prognostic impact of the uptake of this tracer.

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.