Trial Summary
What is the purpose of this trial?This trial involves injecting a special substance into people who have recovered from COVID-19 and then taking detailed body scans to see where the substance goes. This helps doctors understand how different parts of the body are affected after recovering from COVID-19.
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, it does not mention any specific requirements to stop or continue existing medications.
What safety data exists for the treatment [18F]F-AraG, VisAcT, or 2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine?The provided research does not contain specific safety data for [18F]F-AraG, VisAcT, or 2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine. The studies focus on other 18F-labeled compounds and their applications in imaging, particularly for prostate cancer and immune-related adverse events in immunotherapy. Therefore, no direct safety data for the specified treatment is available in the given research.167810
Is the treatment in the trial 'Immune Activation Imaging for COVID-19' a promising treatment?Yes, the treatment is promising because it uses imaging to visualize immune responses in the lungs, which can help doctors identify COVID-19 patients at risk of severe illness. This can improve decision-making and potentially save lives by targeting those who need more intensive care.23459
What data supports the idea that Immune Activation Imaging for COVID-19 is an effective treatment?The available research shows that Immune Activation Imaging, specifically using [18F]F-AraG, is not directly discussed as an effective treatment for COVID-19 in the provided articles. Instead, the research focuses on imaging techniques to monitor immune responses and inflammation in COVID-19 patients. For example, one study discusses using a similar imaging tool, 18F-AzaFol, to visualize activated macrophages, which are important in inflammatory conditions like COVID-19. This imaging can help identify patients at risk of severe disease progression. However, there is no direct evidence in the provided information that supports [18F]F-AraG as a treatment for COVID-19.23459
Eligibility Criteria
This trial is for adults over 18 who've recently had COVID-19, with symptoms starting at least 14 days ago or a positive test if asymptomatic. They must have certain blood cell counts and organ function levels, not be pregnant or breastfeeding, and agree to use two forms of birth control if applicable.Inclusion Criteria
My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.
I am older than 18 years.
Exclusion Criteria
I have had a stem cell or organ transplant from another person.
I have been diagnosed with myelodysplasia syndrome or had lymphoproliferative disease before joining the study.
Treatment Details
The study tests an imaging agent called [18F]F-AraG using PET-CT scans to see how it distributes in the body after COVID-19 infection. Participants will receive up to two microdoses of the tracer; one mandatory scan followed by an optional second scan four months later.
1Treatment groups
Experimental Treatment
Group I: [18F]F-AraGExperimental Treatment1 Intervention
Radiofluorinated imaging agent, \[18F\]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)
Trade name: VisAcT
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Research locations nearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who is running the clinical trial?
CellSight Technologies, Inc.Lead Sponsor
University of California, San FranciscoCollaborator
References
Imaging the Cancer Immune Environment and Its Response to Pharmacologic Intervention, Part 2: The Role of Novel PET Agents. [2021]Although 18F-FDG PET/CT is widely available and is increasingly being used to monitor response to immunotherapy and simultaneously identify immune-related adverse events, there are several challenges in interpreting the results of this investigation, especially early in the course of treatment. It also has limited utility in selecting the optimal type of immunotherapy. As knowledge about immune contexture increases, new targets that may be amenable to imaging are being defined. These exciting advances, coupled with increasingly sophisticated methods for generating radiopharmaceuticals, provide the potential for either replacing or complementing 18F-FDG PET/CT in the selection and monitoring of immunotherapy. Approaches include imaging specific characteristics of immune cell infiltrates or aspects of the tumor microenvironment that are known to be associated with suppression of the innate and adaptive immune response. Following a large body of preclinical work, promising agents that are entering into early clinical evaluation are discussed. We suggest a speculative algorithm as to how these might be used in routine practice, subject to validation in clinical trials.
Can Nuclear Imaging of Activated Macrophages with Folic Acid-Based Radiotracers Serve as a Prognostic Means to Identify COVID-19 Patients at Risk? [2020]Herein, we discuss the potential role of folic acid-based radiopharmaceuticals for macrophage imaging to support clinical decision-making in patients with COVID-19. Activated macrophages play an important role during coronavirus infections. Exuberant host responses, i.e., a cytokine storm with increase of macrophage-related cytokines, such as TNFα, IL-1β, and IL-6 can lead to life-threatening complications, such as acute respiratory distress syndrome (ARDS), which develops in approximately 20% of the patients. Diverse immune modulating therapies are currently being tested in clinical trials. In a preclinical proof-of-concept study in experimental interstitial lung disease, we showed the potential of 18F-AzaFol, an 18F-labeled folic acid-based radiotracer, as a specific novel imaging tool for the visualization and monitoring of macrophage-driven lung diseases. 18F-AzaFol binds to the folate receptor-beta (FRβ) that is expressed on activated macrophages involved in inflammatory conditions. In a recent multicenter cancer trial, 18F-AzaFol was successfully and safely applied (NCT03242993). It is supposed that the visualization of activated macrophage-related disease processes by folate radiotracer-based nuclear imaging can support clinical decision-making by identifying COVID-19 patients at risk of a severe disease progression with a potentially lethal outcome.
Immune Response Visualized In Vivo by [18F]-FDG PET/CT after COVID-19 Vaccine. [2021]Worldwide deployment of COVID-19 vaccines is in progress. Recent immune activation following vaccination can sometimes be seen in fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography ([18F]-FDG PET/CT). As previously evidenced, FDG-avid axillary lymph node(s) are common in patients receiving vaccines against SARS-CoV-2, influenza virus, or human papillomavirus, and reflect a regional immune response. In addition, these findings may also be accompanied by an increased spleen glucose metabolism after the COVID-19 vaccine, which captures a systemic immune response. Hence, we provide here a clinical example demonstrating that immune response could be associated with increased glucose metabolism in lymphoid organs such as lymph nodes and the spleen, which are critical modulators of T cell immunity. We believe that it is of paramount importance that nuclear physicians should be able to recognize clinical and imaging features of such immune responses upon vaccination for COVID-19 and beyond.
FDG PET/CT imaging features and clinical utility in COVID-19. [2022]To determine the imaging findings and potential clinical utility of FDG PET/CT in patients with laboratory-confirmed COVID-19.
124I-Iodo-DPA-713 Positron Emission Tomography in a Hamster Model of SARS-CoV-2 Infection. [2023]Label="PURPOSE">Molecular imaging has provided unparalleled opportunities to monitor disease processes, although tools for evaluating infection remain limited. Coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is mediated by lung injury that we sought to model. Activated macrophages/phagocytes have an important role in lung injury, which is responsible for subsequent respiratory failure and death. We performed pulmonary PET/CT with 124I-iodo-DPA-713, a low-molecular-weight pyrazolopyrimidine ligand selectively trapped by activated macrophages cells, to evaluate the local immune response in a hamster model of SARS-CoV-2 infection.
Impact of the molar activity and PSMA expression level on [18F]AlF-PSMA-11 uptake in prostate cancer. [2022]This two-part preclinical study aims to evaluate prostate specific membrane antigen (PSMA) as a valuable target for expression-based imaging applications and to determine changes in target binding in function of varying apparent molar activities (MAapp) of [18F]AlF-PSMA-11. For the evaluation of PSMA expression levels, male NOD/SCID mice bearing prostate cancer (PCa) xenografts of C4-2 (PSMA+++), 22Rv1 (PSMA+) and PC-3 (PSMA-) were administered [18F]AlF-PSMA-11 with a medium MAapp (20.24 ± 3.22 MBq/nmol). SUVmean and SUVmax values were respectively 3.22 and 3.17 times higher for the high versus low PSMA expressing tumors (p < 0.0001). To evaluate the effect of varying MAapp, C4-2 and 22Rv1 xenograft bearing mice underwent additional [18F]AlF-PSMA-11 imaging with a high (211.2 ± 38.9 MBq/nmol) and/or low MAapp (1.92 ± 0.27 MBq/nmol). SUV values showed a significantly increasing trend with higher MAapp. Significant changes were found for SUVmean and SUVmax between the high versus low MAapp and medium versus low MAapp (both p < 0.05), but not between the high versus medium MAapp (p = 0.055 and 0.25, respectively). The effect of varying MAapp was more pronounced in low expressing tumors and PSMA expressing tissues (e.g. salivary glands and kidneys). Overall, administration of a high MAapp increases the detection of low expression tumors while also increasing uptake in PSMA expressing tissues, possibly leading to false positive findings. In radioligand therapy, a medium MAapp could reduce radiation exposure to dose-limiting organs with only limited effect on radionuclide accumulation in the tumor.
Development of 18F-Labeled Vinyl Sulfone-PSMAi Conjugates as New PET Agents for Prostate Cancer Imaging. [2022]Radiolabeled prostate-specific membrane antigen (PSMA) ligands have been rapidly adopted as part of patient care for prostate cancer. In this study, a new series of 18F-labeled PSMA-targeting agents was developed based on the high-affinity Glu-ureido-Lys scaffold and 18F-vinyl sulfones (VSs), the tumor uptake and tumor/major organ contrast of which could be tuned by pharmacokinetic linkers within the molecules. In particular, 18F-PEG3-VS-PSMAi showed the highest tumor uptake (12.1 ± 2.2%ID/g at 0.5 h p.i.) and 18F-PEG2-VS-PSMAi showed the highest tumor-to-liver ratio (T/L = 3.7 ± 1.0, 4.8 ± 1.2, and 6.3 ± 1.1 at 0.5, 1.5, and 3 h p.i. respectively). Significantly, compared with the FDA-approved 68Ga-PSMA-11, the newly developed 18F-PEG3-VS-PSMAi has an almost double tumor uptake (P < 0.0001) when tested in the same animal model. In conclusion, 18F-VS-labeled PSMA ligands are promising PET agents with prominent tumor uptake and high contrast. The lead agents 18F-PEG2-VS-PSMAi and 18F-PEG3-VS-PSMAi warrant further evaluation in prostate cancer patients.
Diagnostic impact of 18F-FDG PET/CT imaging on the detection of immune-related adverse events in patients treated with immunotherapy. [2022]Label="INTRODUCTION" NlmCategory="BACKGROUND">Immunotherapy is an effective treatment method for cancer cells with humoral and cellular immune mechanisms of action but triggers an inflammatory response and disrupts standard protective immune tolerance. Early detection of immune-related adverse events (irAEs) on PET/CT is crucial for patient management and subsequent therapy decisions. In this study, we aimed to evaluate the impact of 18F-FDG PET/CT on detecting of irAEs in patients receiving immunotherapy.
Novel application of [18F]DPA714 for visualizing the pulmonary inflammation process of SARS-CoV-2-infection in rhesus monkeys (Macaca mulatta). [2022]Label="RATIONALE">The aim of this study was to investigate the application of [18F]DPA714 to visualize the inflammation process in the lungs of SARS-CoV-2-infected rhesus monkeys, focusing on the presence of pulmonary lesions, activation of mediastinal lymph nodes and surrounded lung tissue.
Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. [2023]18F-PSMA 1007 is a promising PET tracer for prostate cancer. We aimed to examine the safety, biodistribution, radiation dosimetry, and clinical effectiveness in Japanese healthy volunteers and patients with prostate cancer.