ABSTRACT
Introduction & Objectives: Urothelial cancer is a lethal disease with a rising incidence. The current imaging modalities for staging, either CT of the chest, abdomen and pelvis or FDG PET/CT, have issues. CT is known to have relatively low sensitivity for detecting low volume metastatic disease, while FDG PET is predominantly renally excreted and has intense activity in the urinary tract, which limits its utility to detect bladder or upper tract lesions, or nodal metastases in close proximity to the urinary tract. Utilizing 89Zr-TLX250, which is predominantly hepatically cleared, may improve imaging in these scenarios. The aim of this study is to explore the feasibility, safety, and utility of Zirconium-89-Girentuximab (89Zr-TLX250) PET/CT in the accurate staging of bladder and urothelial cancer as compared to FDG PET. Material(s) and Method(s): ZipUp is single-arm, phase I trial examining the feasibility, safety, and utility of 89Zr-TLX250 PET/CT in patients either undergoing pre-operative staging of urothelial carcinoma or bladder cancer for curative intent, or with known metastatic urothelial carcinoma or bladder cancer. Following Ethical approval (HREC ID: RGS3940), all participants undergo 89Zr-TLX250 PET/CT and will need to have undergone recent FDG PET/CT for means of comparison (Figure 1. Trial Schema). This trial aims to recruit 10 participants undergoing pre-operative staging prior to planned cystectomy and 10 participants with known metastatic disease. The primary endpoint is feasibility defined by the ability to recruit to the target sample size within the study duration. Secondary endpoints are safety, tolerability and sensitivity/specificity in detecting lymph node metastases (pre-cystectomy group) compared with FDG PET/CT. Result(s): Since May 2021, 15 patients consented to participate, but 2 patients subsequently withdrew. 7 patients did not proceed to dose administration and imaging due to COVID-19 pandemic related supply issues of IMP which would have delayed initiation of treatment. 6 patients have been enrolled with imaging performed. . 5 pre-cystectomy staging group . 1 metastatic group Conclusion(s): If 89Zr-TLX250 PET/CT is proven to be feasible, safe, and effective in staging urothelial cancer, it could improve the appropriate selection of treatment for patients with metastatic or primary urothelial carcinoma or bladder cancer. [Figure presented]Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.
ABSTRACT
Following the wave of COVID and the numerous protocols of INR -self-management for patients with LVAD, it has been demonstrated that patients can monitor and adjust their anticoagulation and achieve better time in therapeutic range (TTR) compared to standard monitoring and care by physicians. To achieve this goal, more INR tests are performed. Here we compare the TTR in self-management versus the standard treatment and the costs of these two strategies in a European context. Using a protocol established at St-Vincent Hospital in Australia, patients were offered to follow a training on anticoagulation and then manage their anti-vitamin K treatment independently (Auto-management). We then compared the TTR and the cost before and under this protocol. Costs are based on Swiss prices and converted into Dollars (1CHF=1.03US $). Test-strip cost $4.8 per unit, the lancet costs a few cents, and the INR machine (CoaguCheck) is available for $810. The combined cost of the blood test and its interpretation by a general physician (GP) is about $50. Since November 2021, 11 patients have been included in the protocol;these included no women, one patient with a HeartWare, and 10 with a HeartMate 3. The patients have been included in the protocol for a cumulative time of 80 months or a mean of 7.3 months per patient. One patient was transplanted, and none died. One patient had a haemorrhagic complication following colonoscopy under therapeutic INR (2.8), no patient suffered thrombosis, and no LVAD replacement was performed. We compare this group during the Standard Care (SC) and Auto-management (AM) period. During SC, the median TTR was 72% (IQR 63-78);during AM it increased to 90% (IQR 77-93). In SC, the INR control cost per day was $9.4 (IQR 6.6-13) on average, which decreased to $2.4 (IQR 1.9-2.6) per day in AM. INR monitoring occurred on average 5.9 (IQR 4.2-8.2) times per month in SC phase;while in AM patients measured their INR 13.1 (IQR 11.7-13.4) times per month. The cost of one day of INR within the therapeutic range was $13 under standard care, $5.0 in the first year on Auto-management. Despite being associated with more INR control, Self-management of anticoagulation by LVAD- patients are less expensive and results in a higher TTR. Self-management also promotes patient independence. It should be encouraged and expanded to other LVAD implant centres. [ABSTRACT FROM AUTHOR] Copyright of Journal of Heart & Lung Transplantation is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
ABSTRACT
Background: Access to rehabilitation services for Aboriginal people following acquired brain injury (ABI) is frequently hindered by challenges navigating: i) complex medical systems, ii) geographical distances from services and iii) culturally insecure service delivery. Healing Right Way is the first randomised control trial (RCT) to address these issues in partnership with multiple health service providers across Western Australia (WA). Aims: To outline the multicomponent Healing Right Way intervention by providing case studies, and describing challenges, facilitators and implications for rehabilitation services. Method: This stepped-wedge cluster RCT involved four metropolitan and four regional sites across WA. Aboriginal adults hospitalised for ABI were recruited from 2018-2021. Intervention components comprised ABI-related cultural security training (CST) for hospital staff, and employment of Aboriginal Brain Injury Coordinators (ABICs) to support ABI survivors for six months post-injury. The primary outcome was quality of life (measured with Euro QOL-5D-3L VAS) at 26 weeks. Secondary outcomes included participants' overall function and disability, anxiety and depression, carer strain, and changes to service delivery across the 26-week follow-up period. Detailed process and cost evaluations were also undertaken. Results: 108 participants were recruited from the participating sites. The CST was delivered across all eight participating hospitals with 250 hospital staff trained. ABICs supported 61 participants, 70% residing in regional, rural or remote areas. Challenges to implementation of the intervention included impacts from COVID-19 responses, hospital staff turnover and availability, recruitment of people with traumatic brain injury and methods for maintaining contact with participants and next-of-kin across locations. Collaboration with Aboriginal health providers and community networks were invaluable to maintaining contact with participants during follow-up, as was telehealth and research partnerships. Discussion/Conclusions: This landmark trial provides a novel multicomponent intervention in an underserviced population to inform muchneeded service improvements for Aboriginal people with ABI across metropolitan and rural settings.
ABSTRACT
BACKGROUND: A novel therapeutic approach using molecularly targeted radiation is currently in development for patients with recurrent GBM. Many tumor types, including GBM, overexpress the L-type amino transporter 1 (LAT-1)4, which is able to internalize the small-molecule amino acid derivative, 4-L-[131I] iodo-phenylalanine (131I-IPA). In preclinical research, combining 131I-IPA with external radiation therapy (XRT) yielded addi- tive cytotoxic effects. Tumoral accumulation of 131I-IPA was confirmed in a proof-of-principle study using single doses of 2-7 GBq 131I-IPA as a monotherapy or in combination with XRT in patients with recurrent GBM. The objective of the IPAX-1 study was to evaluate the safety, tolerability, dosing schedule, and preliminary efficacy of 131I-IPA in combination with secondline radiotherapy in patients with recurrent GBM. METHOD(S): IPAX-1 is a multi-center, open-label, single-arm, dose-finding phase 1/2 study. Key inclusion criteria: 1. Confirmed histological diagnosis of GBM with evidence of first recurrence 2. History of GBM standard therapy 3. >= 6 months since end of first-line XRT 4. Pathologically increased amino acid tumor uptake shown by molecular imaging 5. Current indication for repeat radiation 6. Gross tumour volume of up to 4.8 cm diameter. Treatment: In phase 1 of the study patients received intravenous 131I-IPA at a dose level of 2 GBq administered in one of three different dosing regimens: single dose group with 2 GBq before radiation, 3 (f)-fractionated-parallel group: 3 x 0.67 GBq during XRT and 3 (f)-fractionated-sequential group: 0.67 GBq x 1 -> XRT -> 0.67 GBq x 2. XRT is delivered in 18 fractions of 2 Gy each. RESULT(S): 10 patients were randomized;one patient with Covid related death was withdrawn from analysis. Survival from start of TLX101 therapy showed mPFS2 of 4.33 M (95% -CI 4.18 - 4.48), PFS-6: 18 % and mOS2 of 15.97 M (95% -CI 2.9 - 29.1) at data lock 09/2021. Updated results will be presented at the meeting. CONCLUSION(S): There were no clinically relevant laboratory changes over time. Urinalysis, vital signs, and ECG did not show any clinically relevant changes from baseline. There were no notable differences in safety and tolerability between groups. Injections of single or fractionated doses of 131I-IPA containing a total activity of 2 GBq in combination with XRT in patients with recurrent GBM were safe and well tolerated. Survival data look promising;extension cohort will be treated in a phase II study in Linz;phase 1/2 study in first line setting is planned.
ABSTRACT
Background: Blood pressure (BP) management is imperative in reducing risk of adverse events in continuous flow (CF) left ventricular assist device (LVAD) patients. The gold standard for non-invasive blood pressure (BP) measurement in these patients is Doppler ultrasound, which requires training and dexterity and is not routinely used in the outpatient setting. In the current COVID-19 pandemic era, telehealth assessment has become mandatory to assess and monitor patients. At our institution, we have issued all CF-LVAD patients with a Doppler ultrasound device and an oscillometric BP monitor, and provided training to correctly use these devices. Accuracy of BP measurements in this setting has not been confirmed. Aim: We examined whether Doppler BP obtained by CF-LVAD patients (pts) correlates to Doppler BP obtained by health care workers (HCWs). Methods: CF-LVAD pts were recruited between November 2020 and January 2022. During these routine outpatient follow-up visits, Doppler BP measurements were obtained simultaneously and independently by pts and HCW. BP was taken in a comfortable seating position following 5 minutes rest. Results: A total 223 pairs of simultaneous patient Doppler BP readings and HCW Doppler BP readings were obtained from 38 CF-LVAD patients (87% male, mean age at implant 52 + 14 years, 15 HeartMate3 and 23 HeartWare HVAD, with support duration range 28 - 3492 days). Patient Doppler BP (average 85.9 + 9.8 mmHg) correlated closely with HCW Doppler BP (average 86.1 + 9.6 mmHg), r2=0.90, p<0.0001. There was no significant difference between BP taken by the patient and HCW (p=0.4). The mean difference between the two methods was -0.17 mmHg and the standard deviation was 0.22 mmHg (figure) using Bland-Altman analysis. Conclusions: These results demonstrate that in our patient-population, Doppler-derived blood pressure measurements in CF-LVAD patients were accurate and reliable. This supports the routine use of home Doppler BP measurement and monitoring by CF-LVAD patients, especially in the telehealth era. (Figure Presented).