Brain Metastasis

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 new imaging techniques to better detect tumors in people with brain metastasis. This study focuses on comparing positron emission tomography (PET) combined with magnetic resonance imaging (MRI) against other imaging methods to determine if these newer techniques can more accurately identify cancerous tissue. Improved imaging is important to help locate tumors and guide future cancer treatments. Participants will undergo a single PET/MRI scan using a radiotracer called F-Fluciclovine, followed by a separate MRI scan with a tracer. These imaging methods are performed on the same machine that creates detailed pictures using magnets and radio waves. The PET and MRI scans assess protein levels in tumor tissue, with higher protein levels suggesting tumor presence rather than normal brain tissue. During the study visit, which lasts about three hours, participants will be asked to lie still for 30 to 60 minutes during imaging. Researchers will measure amino acid uptake into tumor tissue to compare imaging results. Patients must be able to complete the scans without requiring intravenous sedation, and medication use for mild anxiety is allowed under specific conditions. All scans and procedures are conducted to monitor tumor presence and treatment changes safely.

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 the best biological dose of 5-Azacitidine combined with PD-1/PD-L1 inhibitors in patients whose tumors no longer respond to these immunotherapies. This Phase I study focuses on patients with locally advanced or metastatic solid tumors where PD-1 or PD-L1 treatments have already been approved. The goal is to find an optimal dose to improve treatment options for these resistant tumors. The study tests six different doses of 5-Azacitidine ranging from 5 to 75 mg/m2, given together with a PD-1/PD-L1 inhibitor such as Pembrolizumab, Nivolumab, or Cemiplimab. The PD-1/PD-L1 inhibitors are administered at standard FDA-approved doses for this purpose. Participants receive these treatments according to the assigned dose group during the study. Participants will be monitored for side effects and tumor response using clinical and laboratory assessments, including imaging scans and blood tests. The main outcome is to measure dose-limiting toxicities and treatment responses within about one month after therapy. Longer-term outcomes like survival and tumor progression will be followed for up to five years. This process helps researchers understand the safety and effects of the drug combination over time.

Researchers are evaluating the use of Gallium-68-DOTATATE PET/MRI in patients with somatostatin receptor-positive (SSTR-positive) central nervous system (CNS) tumors, mainly focusing on meningioma but also including other tumor types such as esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain. The study aims to assess the diagnostic usefulness of this imaging technique, especially in distinguishing tumor recurrence from post-treatment changes, with a particular interest in cases where tumor location limits surgical removal or where patients have higher-grade disease or previous radiation treatment. This is a Phase 4 interventional study sponsored by Weill Medical College of Cornell University.

Researchers are evaluating a new imaging method using 68Ga-MY6349 PET/CT to detect Trop-2 expression in tumor lesions of patients with solid tumors. This study aims to compare the effectiveness of this new PET radiotracer with the standard 18F-FDG PET/CT imaging to identify patients who may benefit from Trop-2 targeted imaging. The study is observational and involves patients with various types of malignant tumors, either newly diagnosed or previously treated. Participants receive a single intravenous injection of the 68Ga-MY6349 tracer and then undergo PET/CT imaging within a set timeframe. They also undergo standard-of-care imaging with 18F-FDG PET/CT either for initial assessment or to detect tumor recurrence. The uptake of the tracer in tumors is measured by the maximum standard uptake value (SUVmax) and compared visually to the standard imaging results. During the study, researchers will assess the feasibility of using 68Ga-MY6349 PET/CT for non-invasive evaluation of Trop-2 expression in tumors. Participants will have both imaging tests and their tumor lesions will be documented and analyzed. The primary focus is on imaging accuracy and tracer uptake within one week. This study is sponsored by The First Affiliated Hospital of Xiamen University and involves adults aged 18 years or older with solid tumors.

Researchers are evaluating a new dual-target imaging agent called 68Ga-RM26-RGD for PET/CT scans in patients with breast, brain, and prostate cancers that express specific receptors (GRPR and integrin αvβ3). This study aims to improve tumor detection by comparing this agent with conventional 18F-FDG and single-target imaging agents, addressing limitations of current imaging methods in detecting tumors with low 18F-FDG uptake or variable receptor expression. Participants will undergo PET/CT scans using intravenous injections of 68Ga-RM26-RGD and one of the comparator agents (18F-FDG, 68Ga-RM26, or 68Ga-RGD) within a two-week period. The dosages for these agents are approximately 1.8-2.2 MBq/kg. Each patient receives scans with both agents to compare imaging performance directly. During the study, researchers will assess diagnostic accuracy and dosimetry of 68Ga-RM26-RGD over about one year. Participants will have multiple PET/CT scans and related evaluations to monitor uptake of the imaging agents in tumors. The study includes safety and diagnostic performance monitoring throughout the participation period.

Researchers are studying patients diagnosed with small-cell lung cancer (SCLC) who have declined prophylactic cranial irradiation (PCI). The study compares the use of a 7-tesla (7t) brain MRI scan to standard care 1.5t or 3t MRI scans to determine if the 7t MRI can detect brain metastases earlier than current methods. Patients must have had a recent standard MRI that showed no brain metastases to participate. Participants will first undergo a 7t MRI brain scan, followed by up to 12 months of standard care MRI scans (either 1.5t or 3t). The study will monitor patients regularly through these scans to observe if and when brain metastases develop. Once brain metastases are confirmed by standard scans, the results will be compared to the earlier 7t MRI images to evaluate the potential for earlier detection. Throughout the study, participants will be followed for up to one year or until brain metastases are detected. The primary outcome is the detection of brain metastases using the 7t MRI at 3, 6, 9, and 12 months after the initial 7t scan. Patients will continue their regular clinical care and surveillance with brain MRI scans. The study involves no treatment changes but focuses on imaging assessment and monitoring.

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts: dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11's effects alone and with pembrolizumab.

Researchers aim to improve understanding and treatment of brain metastases from solid tumors, which currently have limited systemic treatment options. This study focuses on patients with newly diagnosed non-CNS metastatic solid tumors who are at high risk of developing central nervous system (CNS) metastases. By gathering detailed clinical and biological information, including analyses of circulating tumor DNA (ctDNA) from cerebrospinal fluid (CSF) samples, the study seeks to identify new therapeutic targets and develop innovative treatment strategies. The study is organized into three time periods: before the first CNS event (Part A), at the first CNS diagnosis (Part B), and after the first CNS event (Part C). Participants will undergo scheduled collections of plasma, serum, CSF samples, and non-CNS metastatic tumor tissue as applicable, along with brain MRI scans at specific intervals depending on their part in the study. Sample collections and imaging are scheduled annually, every few months, or as clinically indicated, aligned with the participant's cancer type and study period. Participants will have regular assessments including imaging and biological sample collections to monitor disease progression and tumor biology. Researchers will analyze the epidemiology and biology of CNS metastases over approximately eight years. Study procedures include lumbar punctures for CSF collection, brain MRIs, and collection of tumor tissue when possible. Participants' safety and life expectancy are considered, and follow-up will continue throughout the study duration to support data collection and understanding of CNS metastases.