Neoplasm

This research aims to understand how patients with cancer respond to COVID-19 vaccination by studying the levels of protective antibodies over time. The focus is on individuals with solid organ malignancies receiving various anti-cancer treatments such as chemotherapy, targeted therapy, and immunotherapy, as well as those who have been disease-free for at least six months. Since cancer patients were excluded from initial vaccine trials, this study seeks to fill knowledge gaps about vaccine safety and effectiveness in this group. Participants include cancer patients who are either undergoing active treatment or are disease-free for six months or more. They are grouped based on their treatment type: chemotherapy, targeted therapy, immunotherapy, or disease-free status. The study involves monitoring antibody trends related to COVID-19 infection and vaccination at multiple time points over a 12-month period. During the study, researchers will collect blood samples to measure neutralizing and spike antibody levels every three months for up to one year. Participants will be followed to track their immune response depending on their cancer treatment and biological aging status. The study will also assess how antibody levels change over time and correlate with different treatments and patient characteristics. Safety and consent are carefully monitored throughout the trial.

This research evaluates (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor positive (ER+) and HER2-negative breast cancer. The study is open-label and includes two parts: a pharmacokinetic (PK) part to understand how the body processes the drug, and a treatment part to assess the drug's effect on tumor growth by measuring the biomarker Ki-67. The trial is sponsored by Atossa Therapeutics, Inc. and aims to determine if (Z)-endoxifen can slow or stop tumor growth in this patient group. Participants in the PK part receive daily (Z)-endoxifen capsules at doses of 20 mg, 40 mg, or 80 mg, with some also receiving a monthly injection of goserelin, which temporarily stops estrogen production by the ovaries. The treatment part uses a combination of (Z)-endoxifen at 40 mg daily plus monthly goserelin injections. After 4 weeks, tumor tissue is sampled via biopsy to measure Ki-67 levels. If Ki-67 is 10% or less, participants may continue treatment for up to 24 weeks; if greater than 10%, they proceed to surgery earlier. Participants attend regular visits for treatment and assessments, including blood tests and breast biopsies to monitor drug levels and tumor response. The main outcomes measured include (Z)-endoxifen blood concentrations and tumor Ki-67 reduction after 4 weeks, along with tumor response after 24 weeks. Study participation lasts up to 6 months, followed by surgery and a one-month follow-up to evaluate safety and treatment effects.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

Researchers are evaluating the safety and appropriate dose of increasing levels of the radioactive drug 131I-TLX101, given by intravenous infusion, combined with the best standard care in adults newly diagnosed with glioblastoma, a type of brain cancer. This open-label, single-arm study is conducted across multiple centers and aims to understand how patients tolerate this treatment alongside standard therapies. Participants receive escalating doses of 131I-TLX101 through an intravenous infusion along with the standard chemoradiation therapy known as the Stupp regimen, beginning 3 to 6 weeks after surgical removal of the tumor. The study includes a dose-finding phase to establish the recommended dose, with safety monitored throughout. The radioactive drug is administered in ascending doses, and the study observes participants for up to 62 weeks. During the study, participants will undergo regular safety assessments including laboratory tests of liver and kidney function, monitoring for adverse events, and evaluations of treatment-related toxicities for up to 62 weeks. Researchers will track the incidence and severity of dose-limiting toxicities and treatment-emergent adverse events. Participants must comply with radiation safety guidelines and attend scheduled visits for monitoring. The total study duration from screening until the end is about 62 weeks.

Researchers are evaluating the optimization of 18F-DOPA PET/CT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinson's disease or Lewy body dementia. The study aims to improve image quality using a new digital PET/CT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PET/CT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

Researchers are evaluating the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MR) for diagnosing primary and metastatic cancer lesions, detecting recurrence, and assessing pathological response across various cancer types. The study is observational and aims to assess how well these imaging methods perform compared to standard diagnosis using histopathology and follow-up. Participants with different types of cancer undergo imaging with 18F-FAPI-04 PET/CT and PET/MR scans. The tracer 18F-FAPI-04 is injected into patients before the scans. Tumor uptake is measured by maximum standard uptake value (SUVmax) and tumor to background ratio (TBR). The imaging results are compared using sensitivity, specificity, positive predictive value, negative predictive value, and accuracy to evaluate diagnostic performance. During the study, participants are assessed through these imaging procedures to monitor tumor presence, recurrence, or response to treatment. The primary outcome is the diagnostic performance evaluated over one year. The study includes participants aged 18 to 90 years and involves informed consent and ethical approval. The total duration and follow-up details are based on imaging and clinical evaluations to confirm findings.

Researchers are evaluating a new dual targeting PET radiotracer called 18F-FAPI-Biotin in patients with various types of cancer. This tracer aims to improve tumor detection by targeting both fibroblast activation protein, which is highly expressed in many cancer stromas, and biotin, which is overexpressed in tumor cells but underexpressed in normal cells. The study focuses on assessing the safety, how the tracer distributes in the body, and the radiation dosimetry compared to existing tracers like 18F-FAPI and 18F-FDG. Participants receive an intravenous dose of 148-296 MBq of 18F-FAPI-Biotin. PET imaging is conducted dynamically at multiple time points: 3 minutes, 15 minutes, 30 minutes, 60 minutes, and 120 minutes after injection. This allows researchers to observe the tracer's pharmacokinetics and dosimetry across different organs and tumors. The study is classified as an early phase 1 trial. During the study, patients undergo PET/CT scans at the specified time points following tracer injection. Researchers monitor the dosimetry of normal organs and tumors from immediately after injection up to 120 minutes later. Safety assessments include tracking adverse events for up to one week using standard criteria. The total participation duration includes imaging sessions and safety monitoring to evaluate the tracer's distribution and potential side effects.

Researchers are evaluating the diagnostic performance of two PET tracers, 18F-FDG and 68Ga-FAPI-46, in female patients with estrogen receptor-positive (ER+) breast cancer. This pilot study focuses on patients with locally advanced, recurrent, or metastatic breast cancer and aims to determine if 68Ga-FAPI-46 detects more lesions than 18F-FDG, potentially leading to more accurate staging and treatment decisions. The study is sponsored by Maastricht University Medical Center and is conducted as a Phase 2 interventional trial. All participants will undergo an additional 68Ga-FAPI-46 PET/CT and PET/MRI scan before starting breast cancer treatment. These imaging exams will be performed within 20 working days from diagnosis and alongside the standard 18F-FDG PET/CT or PET/MRI scans. The study focuses on comparing these two diagnostic tracers' accuracy in detecting cancer lesions in ER+ breast cancer patients. Participants will be followed from diagnosis until both PET exams are completed. The researchers will collect data to help calculate sample size for future studies and explore the feasibility of taking biopsies from lesions identified by the new tracer. Safety and ability to complete imaging procedures will be monitored. The total participation duration covers the time needed to conduct both imaging exams and any related assessments.

Researchers are evaluating the use of 18F-Fluciclovine positron emission tomography (PET) as a biomarker to measure the response or progression of brain metastasis in participants treated with stereotactic radiosurgery (SRS). This pilot imaging study focuses on adults diagnosed with brain metastases who are planned to receive SRS treatment. The study is sponsored by Baptist Health South Florida and is a Phase 1 clinical trial. Participants will undergo an 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). They will then receive a single dose of SRS as part of their standard care. A second 18F-fluciclovine PET scan will be performed approximately 8 weeks after the SRS treatment, with a window of plus or minus 2 weeks. During PET scans, participants receive a 5-mCi dose of 18F-fluciclovine through intravenous injection, with imaging data collected up to 25 minutes post-injection. Throughout the study, participants will be monitored using PET imaging to evaluate changes in standardized uptake values (SUV) over 8 weeks, which helps assess tumor response. Tumor control will also be evaluated at 12 months. The study involves standard imaging, including MRI and PET scans, and tracks participant safety and treatment progress. Total participation timelines include initial scans at SRS planning and follow-up imaging about 8 weeks later, with tumor control assessed after one year.

Researchers are evaluating whether 18F-fluciclovine (Axumin®) PET imaging can help doctors distinguish between true tumor growth and other changes in children with high-grade gliomas, including diffuse midline glioma. This distinction is important because true tumor progression may require a change in treatment, while post-treatment changes usually do not. Conventional MRI scans cannot reliably make this differentiation, so this study aims to see if 18F-fluciclovine PET imaging can serve as a useful diagnostic tool. Participants will receive a single intravenous injection of 18F-fluciclovine before undergoing a combined PET-MRI scan. This imaging process is designed to assess tumor status by detecting physiological changes. The study focuses on children and young adults aged 1 to under 21 years with measurable high-grade gliomas or diffuse midline gliomas. The study is an early phase 1 trial, and treatment involves only this one-time imaging procedure. During the study, researchers will analyze the imaging results and compare them to histopathology findings within four weeks and evaluate safety over six months. Participants will be monitored for any side effects related to the imaging agent. The study will assess the usefulness and safety of 18F-fluciclovine PET-MRI in guiding treatment decisions for pediatric high-grade glioma. Participation lasts through these assessments, with imaging and follow-up evaluations scheduled accordingly.