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Ziel/Aim The global SARS-CoV-2 vaccination campaign brought attention to a recent pitfall in tumor staging by PET/CT. Several publications reported a non-specific F-18-FDG tracer uptake in axillary lymph nodes after COVID-19 vaccination. Ga-68-FAPI PET/CT is a new oncologic imaging tool that may overcome this limitation. Methodik/Methods For this purpose, we compared the tracer uptake in a head-to-head and same-day F-18-FDG and Ga-68-FAPI PET/CT study. 11 patients from our prospective database (NCT04571086) were included showing vaccine-related tracer uptake in axillary lymph nodes up to 6 weeks after COVID- 19 vaccination. Ergebnisse/Results Among the total of 11 patients, all (n = 11) showed visual positive uptake in the lymph nodes ipsilateral to the injection side on F-18-FDG PET. None (n = 0) of the included patients showed significant tracer uptake on Ga-68-FAPI PET. Follow-up imaging confirmed reactive nodal uptake in all patients. The tumor detection efficacy for these patients was 73 % for F-18-FDG and 94 % for Ga-68-FAPI. Schlussfolgerungen/Conclusions In our case series, Ga-68-FAPI demonstrated resistance to vaccine-related pitfalls while presenting superior tumor detection.
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INTRODUCTION AND OBJECTIVE: Patients with non-muscleinvasive bladder cancer (NMIBC) that recurs after treatment with intravesical Bacillus Calmette-Guerin (BCG) must weigh the risk of progression of bladder cancer and loss of a window of potential cure with medical therapy against the risk of morbidity and loss of quality of life (QOL) with radical cystectomy. The CISTO Study (NCT03933826) is a pragmatic, prospective observational cohort study comparing medical therapy (i.e., intravesical therapy or systemic immunotherapy) with radical cystectomy for recurrent highrisk NMIBC. Here we report on the design and progress of the CISTO Study. METHODS: 900 patients with recurrent high-risk NMIBC that has failed first-line BCG and who have chosen to undergo standard of care treatment will be enrolled. Patient stakeholders helped determine the primary outcome: 12-month patient-reported QOL using the EORTC QLQ-C30. Secondary outcomes include urinary and sexual function, decisional regret, financial distress, healthcare utilization, return to work/normal activities, progression, and recurrence-free, metastasis-free, and overall survival. Participants will be followed for up to 3 years. RESULTS: Enrollment is active at 32 sites across the US, including 23 university-based centers and 9 community sites. As of November 1, 2021, 173 participants have been enrolled, 104 of whom chose medical therapy and 69 of whom chose radical cystectomy. The completion rate for the primary outcome of QOL at 12 months is 94% (15 out of 16 participants to date). The inclusion of electronic consent and collection of PROs allowed recruitment and follow-up to continue remotely during the COVID-19 pandemic. Significant pandemic-related challenges have included slow study start-up at sites, staffing, periods of suspension, and delays in patients obtaining care. Strategies to address these challenges include improved methods for onboarding and training sites, all-site communication, confirming study eligibility, ing EHR data, and remote monitoring while adhering to the highest study standards. CONCLUSIONS: The CISTO Study will compare patient reported outcomes for those undergoing medical therapy with radical cystectomy for recurrent high-risk NMIBC. The CISTO Study has the potential to fill critical evidence gaps and provide for personalized, patient-centered care.
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INTRODUCTION AND OBJECTIVE: The COVID-19 pandemic has impacted various clinical and research processes in urologic care. As part of a pragmatic clinical trial in bladder cancer, we collected information regarding the impact of COVID-19 at participating sites, which provides insight into how the pandemic has imposed constraints on clinical bladder cancer care and research. METHODS: Starting in May 2020, we distributed a monthly survey to sites participating in CISTO (Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer, NCT0393382). The survey included questions about interruptions in routine clinical bladder cancer care, specifically assessing elective surgery restrictions, impact on radical cystectomy, TURBT, office cystoscopies, intravesical therapy, and intravesical bacillus Calmette- Guerin (BCG) supply. We report survey responses for sites that responded to > 50% of the monthly surveys from May 2020 to October 2021. RESULTS: From May 2020 through October 2021, 21 sites (66%) had > 50% monthly response rate. The time periods of greatest limitations on bladder cancer procedures (Figure 1) were May-July 2020, Dec-Jan 2020/2021, and Sept-Oct 2021, corresponding to the peak waves of COVID-19 infections. Elective surgery was most affected, with limitations or holds in those time periods at up to 76%, 38%, and 28% of CISTO sites, respectively. Most of the restrictions involved surgeries that required inpatient stays, potential intensive care unit admission, and staffing shortages. 9 sites (28%) experienced transient BCG shortages during the survey period. CONCLUSIONS: Clinical activity was most limited during the initial COVID-19 surge in Spring/Summer 2020. Despite higher COVID- 19 infection rates in subsequent waves, bladder cancer clinical activity has been maintained at CISTO sites throughout the COVID pandemic. Periodic BCG shortages continue to affect bladder cancer care across the US. (Figure Presented).
ABSTRACT
The Covid-19 pandemic has caused a major health crisis in France for about 1 year, forcing patients and healthcar professionals to change their approach to chronic disease Diabetes, which was quickly considered to be a medical situation at risk of a severe form of SARS-CoV-2 infection has therefore been the subject of very particular attention both in the daily glycemic monitoring and in the different car options (hospitalization, outpatient consultations), leading to a reorganization of care as profound as it is sudden. Ii this context, the reorganization of the diabetology unit and that of the outpatient diabetological consultation have benefited from the development of telemedicine solution currently available (teleconsultation, telemonitoring) in order to maintain good quality diabetes care. This unprecedented situation has opened up many prospects for improving the care of diabetic patients, even in the absence of any major public health crisis.
ABSTRACT
The COVID-19 pandemic has compelled the French government to impose confinement measures to stem the spread of the coronavirus. These measures may have had a potential impact on the glycemic control of diabetic patients. Within this context, telemedicine appears to be a viable option for follow-up appointments of diabetic patients. To assess this theory, we simultaneously led a prospective observational study during the novel coronavirus pandemic at Strasbourg's teaching hospital and at a private medical office to evaluate glycemic control in 491 diabetic patients either attending a telehealth appointment (n = 338) or whom in-person consultation had been postponed by 6 months (n = 153). Surveys were collected to assess both the patients’ and the physicians’ satisfaction. A decrease in average glycated hemoglobin (HbA1c) was observed among patients from the telehealth appointment group: ΔHbA1c = −0.33% (n = 175) as well as the other group: ΔHbA1c = −0.13% (n = 92) 3 months after the beginning of the study. Patients belonging to the telehealth appointment group at Strasbourg's teaching hospital (n = 97) experienced a decrease in their HbA1c average from 7.65 ± 1.19% to 7.18 ± 0.9%, while patients from the same group attending a private medical office (n = 78) also experienced a decrease from 7.28 ± 0.80% to 7.11 ± 0.79%. Ninety-two percent of patients were satisfied with the telehealth appointment, think it could be a virtual alternative to in-person consultation and would recommend it to other diabetic patients. Even though seven out of eight diabetologists had never offered telehealth appointments to their patients prior to the COVID-19 pandemic, all of them hope to provide such services to their patients once the health crisis is over. The tendency towards a decrease in HbA1c levels within our cohort should be qualified due to missing data caused by the disruption in data collection during the COVID-19 pandemic. Evaluation and assessment of the cohort's glycemic control 6 months after the beginning of the study could help confirm these results.