Publications by authors named "Giganti M"
Purpose: Adaptive radiotherapy (ART) may improve treatment quality by monitoring variations in patient anatomy and incorporating them into the treatment plan. This systematic review investigated the role of artificial intelligence (AI) in computed tomography (CT)-based ART for head and neck (H&N) cancer.
Methods: A comprehensive search of main electronic databases was conducted until April 2024.
Article Synopsis
- The study aimed to create machine learning models to predict pathological complete response (pCR) in breast cancer patients after neoadjuvant chemotherapy using data from FDG PET/CT scans.
- 52 newly diagnosed breast cancer patients had their tumors and lymph node metastases segmented, and various features, both clinical and radiomic, were collected and analyzed.
- The results indicated that models using radiomic features from PET scans, particularly when including data from lymph nodes, performed better in predicting pCR compared to those based on clinical or CT data alone.
Background: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory illness among young children. Human immunodeficiency virus (HIV)-exposed, uninfected (HEU) children experience a higher burden of RSV disease and have immune abnormalities that may influence their responses to live-attenuated RSV vaccines.
Methods: In a pooled analysis of clinical trials of 7 live-attenuated, intranasal RSV vaccines conducted by the IMPAACT Network among children 6 to <25 months of age with serum RSV-neutralizing titers of <1:40, the infectivity and immunogenicity of these vaccines were compared among HEU and HIV-unexposed, uninfected (HUU) children.
The present study investigates the possible use of manganese (Mn)-based liposomal formulations for diagnostic applications in imaging techniques such as magnetic resonance imaging (MRI), with the aim of overcoming the toxicity limitations associated with the use of free Mn. Specifically, anionic liposomes carrying two model Mn(II)-based compounds, MnCl (MC) and Mn(HMTA) (MH), were prepared and characterised in terms of morphology, size, loading capacity, and in vitro activity. Homogeneous dispersions characterised mainly by unilamellar vesicles were obtained; furthermore, no differences in size and morphology were detected between unloaded and Mn-loaded vesicles.
View Article and Find Full Text PDFBackground: We evaluated the fully human polyclonal antibody product SAB-185 in a phase 3 trial for COVID-19.
Methods: Nonhospitalized high-risk adults within 7 days of symptom onset were randomized 1:1 to open-label SAB-185 3840 units/kg or casirivimab/imdevimab 1200 mg. Noninferiority comparison was undertaken for pre-Omicron population (casirivimab/imdevimab expected to be fully active) and superiority comparison for the Omicron population (casirivimab/imdevimab not expected to be active).
Background: Reliable biomarkers of coronavirus disease 2019 (COVID-19) outcomes are critically needed. We evaluated associations of spike antibody (Ab) and plasma nucleocapsid antigen (N Ag) with clinical outcomes in nonhospitalized persons with mild-to-moderate COVID-19.
Methods: Participants were nonhospitalized adults with mild-to-moderate COVID-19 enrolled in ACTIV-2 between January and July 2021 and randomized to placebo.
Article Synopsis
- Outpatient treatment of COVID-19 using subcutaneous monoclonal antibodies (mAbs) could simplify logistics compared to intravenous delivery.
- In a clinical trial with 211 participants, the BMS mAbs did not show significant benefits in symptom improvement or viral load reduction compared to placebo, despite being safe with fewer severe adverse events reported.
- The results suggest that subcutaneous administration of BMS mAbs may not be effective for low-risk COVID-19 patients, potentially due to how the body absorbs mAbs through this method.
Article Synopsis
- Monoclonal antibodies are an important treatment for COVID-19, and a study compared the effects of single vs. dual mAb treatments, specifically amubarvimab and romlusevimab.
- The study found that dual-active mAbs resulted in a quicker reduction of viral load in patients, though hospitalizations and death rates were similar between the two treatment types.
- Additionally, dual-active therapy showed a lower incidence of resistance mutations compared to single-active treatment.
Objective: HIV treatment regimen during pregnancy was associated with preterm delivery (PTD) in the PROMISE 1077 BF trial. Systemic inflammation among pregnant women with HIV could help explain differences in PTD by treatment regimen. We assessed associations between inflammation, treatment regimen, and PTD.
View Article and Find Full Text PDFPurpose: Dual-energy X-ray absorptiometry (DXA) is the gold standard for measuring bone mineral density (BMD) with tolerable error rate, high precision, and excellent consistency. Our objective was to investigate the frequency and distribution of errors in a cohort of patients with Thalassemia major (TM).
Methods: We reviewed the DXA examinations of 340 patients with β-TM followed by our institution, acquired in different imaging centers between 2009 and 2019.
Objective: We established normal ranges for native T1 and T2 values in the human liver using a 1.5 T whole-body imager (General Electric) and we evaluated their variation across hepatic segments and their association with age and sex.
Materials And Methods: One-hundred healthy volunteers aged 20-70 years (50% females) underwent MRI.
Background: With the emergence of SARS-CoV-2 variants resistant to monoclonal antibody therapies and limited global access to therapeutics, the evaluation of novel therapeutics to prevent progression to severe COVID-19 remains a critical need.
Methods: Safety, clinical and antiviral efficacy of inhaled interferon-β1a (SNG001) were evaluated in a phase II randomized controlled trial on the ACTIV-2/A5401 platform (ClinicalTrials.govNCT04518410).
Article Synopsis
- Clinical trials for COVID-19 therapeutics often measure antiviral activity by assessing changes in nasal SARS-CoV-2 RNA levels, typically using statistical methods like ANCOVA or MMRM.
- Using single imputation for results below the assay’s lower limits of quantification (LLoQ) can introduce bias in estimating treatment effects.
- The article underscores best practices for analyzing quantitative viral RNA data, emphasizing the importance of detailing assay specifics, completeness summaries, and considering values below LLoQ as censored measurements.
Understanding variant-specific differences in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral kinetics may explain differences in transmission efficiency and provide insights on pathogenesis and prevention. We evaluated SARS-CoV-2 kinetics from nasal swabs across multiple variants (Alpha, Delta, Epsilon, Gamma) in placebo recipients of the ACTIV-2/A5401 trial. Delta variant infection led to the highest maximum viral load and shortest time from symptom onset to viral load peak.
View Article and Find Full Text PDFBackground: There is little information regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA as a predictor for clinical outcomes in outpatients with mild-to-moderate coronavirus disease 2019 (COVID-19).
Methods: Anterior nasal (AN) and plasma SARS-CoV-2 RNA data from 2115 nonhospitalized adults who received monoclonal antibodies (mAbs) or placebo in the ACTIV-2/A5401 trial were analyzed for associations with hospitalization or death.
Results: One hundred two participants were hospitalized or died through 28 days of follow-up.
Objectives: In this study, we developed a radiomic signature for the classification of benign lipid-poor adenomas, which may potentially help clinicians limit the number of unnecessary investigations in clinical practice. Indeterminate adrenal lesions of benign and malignant nature may exhibit different values of key radiomics features.
Methods: Patients who had available histopathology reports and a non-contrast-enhanced CT scan were included in the study.
Telemedical technologies provide significant benefits in sports for performance monitoring and early recognition of many medical issues, especially when sports are practised outside a regulated playing field, where participants are exposed to rapidly changing environmental conditions or specialised medical assistance is unavailable. We provide a review of the medical literature on the use of telemedicine in adventure and extreme sports. Out of 2715 unique sport citations from 4 scientific databases 16 papers met the criteria, which included all research papers exploring the use of telemedicine for monitoring performance and health status in extreme environments.
View Article and Find Full Text PDFBackground: Camostat inhibits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vitro. We studied the safety and efficacy of camostat in ACTIV-2/A5401, a phase 2/3 platform trial of therapeutics for COVID-19 in nonhospitalized adults.
Methods: We conducted a phase 2 study in adults with mild-to-moderate COVID-19 randomized to oral camostat for 7 days or a pooled placebo arm.
Nowadays, coronary computed tomography angiography (CCTA) has a role of paramount importance in the diagnostic algorithm of ischemic heart disease (IHD), both in stable coronary artery disease (CAD) and acute chest pain. Alongside the quantification of obstructive coronary artery disease, the recent technologic developments in CCTA provide additional relevant information that can be considered as "novel markers" for risk stratification in different settings, including ischemic heart disease, atrial fibrillation, and myocardial inflammation. These markers include: (i) epicardial adipose tissue (EAT), associated with plaque development and the occurrence of arrhythmias; (ii) late iodine enhancement (LIE), which allows the identification of myocardial fibrosis; and (iii) plaque characterization, which provides data about plaque vulnerability.
View Article and Find Full Text PDFImportance: Development of effective, scalable therapeutics for SARS-CoV-2 is a priority.
Objective: To test the efficacy of combined tixagevimab and cilgavimab monoclonal antibodies for early COVID-19 treatment.
Design, Setting, And Participants: Two phase 2 randomized blinded placebo-controlled clinical trials within the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-2/A5401 platform were performed at US ambulatory sites.
Article Synopsis
- A phase 2 and 3 clinical trial was conducted to evaluate the safety and effectiveness of two monoclonal antibodies, amubarvimab and romlusevimab, in treating patients with SARS-CoV-2 who are at high risk for severe illness.
- *The trial involved 807 participants across multiple countries, showing that the antibody combination significantly reduced hospitalizations and deaths by 79% compared to a placebo group, with fewer severe adverse events reported.
- *However, a limitation of the study is that the majority of participants were unvaccinated against COVID-19, which may impact the generalizability of the results.
Article Synopsis
- Many clinical trials for COVID-19 treatments assess antiviral effectiveness by monitoring changes in nasal SARS-CoV-2 RNA levels.
- Using methods like ANCOVA or MMRM and filling in missing data (imputation) can distort treatment effect estimates.
- The paper emphasizes best practices for data analysis, recommending the careful treatment of measurements below the lower limits of quantification (LLoQ) and full transparency regarding assay details and participant outcomes.
Purpose: Percutaneous ablative treatments in the kidney are now standard options for local cancer therapy. Multimodality image guidance, combining two 3D image sets, may improve procedural images and interventional strategies. We aimed to assess the value of intra-procedural cone beam computed tomography (CBCT) with magnetic resonance (MR) or CT imaging fusion technique in the guidance of percutaneous microwave ablation (MWA) of renal neoplasms.
View Article and Find Full Text PDFMagnetic resonance imaging (MRI) is a non-invasive powerful modern clinical technique that is extensively used for the high-resolution imaging of soft tissues. To obtain high-definition pictures of tissues or of the whole organism this technique is enhanced by the use of contrast agents. Gadolinium-based contrast agents have an excellent safety profile.
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