Bethesda

Researchers are evaluating the use of an imaging agent called 18F-DCFPyL to detect how localized prostate cancer responds to treatment. The study focuses on men aged 18 years and older with newly diagnosed, intermediate or high-risk prostate cancer who do not have distant metastatic disease and are scheduled to receive stereotactic body radiation therapy SBRT with or without androgen deprivation therapy ADT. The trial aims to improve early detection of disease persistence or recurrence using advanced imaging techniques. Participants will undergo standard prostate cancer treatment with SBRT, sometimes combined with ADT. They will receive multiple 18F-DCFPyL PETCT scans and multiparametric MRI scans before, during, and after treatment. Imaging includes an injection of 18F-DCFPyL followed by PETCT scans about 1 to 2 hours later, with scans repeated at baseline, 8 weeks after ADT initiation if applicable, 6 months after SBRT, and if recurrence occurs. The study will include up to 100 men divided into groups based on treatment plans. During the study, participants will have medical history reviews, physical exams, blood and urine tests, and quality of life questionnaires. They will provide tumor samples from prior biopsies. Follow-up visits will be scheduled one month after treatment, then every three months for a year, and every six months for an additional year to monitor imaging responses and overall health. Researchers will assess imaging results to understand treatment effects and monitor biochemical control over up to two years.

Researchers are evaluating a new PET imaging tracer called 18FFAPI-74 to detect cancer by targeting the fibroblast-activation protein FAP found in cancer-associated fibroblasts. This study aims to compare 18FFAPI-74 PET scans to the standard 18F-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytomaparaganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute NCI. Participants will receive an intravenous dose of 18FFAPI-74 before undergoing PETCT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by 18FFAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline 18FFAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

Multiple myeloma MM is a type of blood cancer that currently has no cure and often returns after treatment, leading to a survival time of about 5 to 8 years after diagnosis. Researchers are studying whether a new imaging substance called 18F-fluciclovine can detect MM more effectively than the currently used 18F-FDG. This trial is a phase 2 study focused on adults with MM, including those newly diagnosed or with relapsedrefractory disease, aiming to improve early detection of returning disease. Participants will receive an injection of the radiotracer 18F-fluciclovine and undergo PETCT scans at three different times initially, after treatment for newly diagnosed participants or six months for relapsedrefractory participants, and at disease progression or after 5 years. Each visit includes two PETCT scansone with 18F-FDG and one with 18F-fluciclovineas well as an optional MRI scan and a bone marrow biopsy. The study compares the imaging results from both tracers to assess which better detects MM lesions. During the study, participants will attend three visits where tests and scans will be performed, possibly spread over 30 days per visit. Blood tests, imaging scans, and bone marrow samples will help researchers measure disease volume, minimal residual disease, and response to treatment. Safety of the new radiotracer is also monitored shortly after each dose. Participation may last up to 5 years, with follow-up visits scheduled to track disease progression and imaging results.

Researchers are evaluating a new drug called Aza-TdC for people aged 18 and older with advanced solid tumors whose cancer has worsened after standard treatments or has no effective therapy. This early-phase trial aims to test the safety, tolerability, and best dose of oral Aza-TdC, which is designed to reactivate tumor suppressor genes by inhibiting DNA methylation, potentially slowing tumor growth. Participants will take Aza-TdC by mouth in 21-day cycles. For the first two weeks of each cycle, they take the drug once daily for five days followed by two days off, then no drug in the third week. The study uses an accelerated dose escalation approach and may allow dose increases within participants. Testing includes blood samples for drug levels and gene activity, tumor scans every six weeks, and biopsies in some cases to study drug effects on tumors. During the study, participants undergo screening with medical history, blood and urine tests, heart electrical activity tests, and tumor imaging. Blood and pregnancy tests occur regularly, along with tumor biopsies for some participants. Researchers will measure safety, drug behavior in the body, gene reactivation, and tumor response. Treatment cycles continue as long as the drug is tolerated and cancer remains stable or improves. The study is sponsored by the National Cancer Institute and lasts until September 2026.

Researchers are investigating whether the enzyme phosphodiesterase 4B PDE4B is reduced in the brains of people with major depressive disorder MDD experiencing a major depressive episode MDE. This study will also explore how well a new radioactive tracer, 18FPF-06445974, can measure PDE4B in the brain, including the best scan length and reliability, as well as how PDE4B levels relate to clinical rating scales. Additionally, the study will assess if PDE4B binding can be blocked by the drug apremilast. Participants will undergo up to five clinic visits including screening, physical exams, blood tests, and heart function tests. Imaging involves MRI scans followed by PET scans where the radioactive tracer is injected intravenously through a catheter. During the PET scan, participants will be monitored closely, including blood pressure and heart rate, and blood samples will be collected via a wrist artery catheter. Some participants may have a second PET scan, a lung scan immediately after the brain scan, or receive oral apremilast to evaluate PDE4B blocking. Throughout the study, participants will complete psychiatric assessments and questionnaires about their mental state. Researchers will measure PDE4B distribution volume in the brain and examine its correlation with clinical symptoms. Safety monitoring includes vital signs before, during, and after PET scanning. The study aims to complete within several years, with the primary outcome focused on measuring PDE4B density and related scan parameters to better understand MDD.

Researchers are studying tumors that have somatostatin receptors SSTRs on their surface, which include tumors in the lung, head and neck, digestive tract, kidneys, and adrenal glands. This trial tests a drug called 212PbVMT-Alpha-NET, which is designed to target these receptors and potentially help shrink tumors that have spread and cannot be removed surgically. The study focuses on people aged 18 and older with these specific types of tumors and aims to determine the maximum tolerated dose and safety of the drug. Participants receive 212PbVMT-Alpha-NET through a vein on the first day of four 8-week cycles. Some participants will also receive a related imaging drug, 203PbVMT-Alpha-NET, a few days before the first two treatment cycles to allow whole-body scans that track how the drug spreads in the body. After each infusion, participants stay in the hospital for a few nights and have weekly blood tests during each treatment cycle. The study includes dose escalation to find the best dose and then dose expansion at that dose level. Throughout the study, participants undergo physical exams, blood and urine tests, imaging scans including PETCT and SPECTCT, heart function tests, and may provide tumor tissue samples if needed. Follow-up visits occur about 30 days after treatment ends, then every 12 weeks for up to 3 years, with annual check-ins continuing up to 6 years after the last treatment. Researchers monitor safety, response to treatment, and survival outcomes during this time.

Researchers are gathering information and biological samples from people aged 3 to 100 years who have allergic or sinus diseases, such as asthma, eczema, pollen allergies, and other related conditions. This study aims to build a repository of clinical, laboratory, and diagnostic data to better understand these diseases and support future research. Participants include those with suspected or confirmed allergic and atopic disorders evaluated by allergist-immunologists and rhinologists. Participants will visit the NIH Clinical Center for clinical evaluation and sample collection, including blood, skin swabs, nasal brushings, nasal fluid, and urine. Some may have allergy skin prick tests and lung function tests. Additional tissue samples may be gathered during routine medical procedures if applicable. Visits occur at baseline, annually, and at the end of the study over 1 to 3 years, with some telehealth visits and the option to send in samples. During the study, participants complete questionnaires about their symptoms and health. Researchers collect and store data and samples for future medical research. The study tracks clinical and diagnostic information over time, but no experimental treatments are provided. The total participation period spans 1 to 3 years, with ongoing evaluation and monitoring at scheduled visits.

Researchers are investigating whether the Lyme disease bacteria, Borrelia burgdorferi, remain alive in patients after antibiotic treatment and whether this persistence causes ongoing symptoms. The study aims to better define diagnostic criteria for Lyme disease and support the development of future treatment trials by following a well-characterized group of patients with post-treatment Lyme disease syndrome PTLDS and various control groups. Participants include those with chronic Lyme disease, Lyme arthritis, multiple sclerosis, previous Lyme infection with full recovery, seropositive individuals without symptoms, and healthy volunteers. Participants undergo physical exams and tests including blood tests, white blood cell collection or blood draw, lumbar puncture, brain MRI, neuropsychological assessments, and sometimes hearing tests and urine collection. Those testing positive for the bacteria are monitored every 3 to 6 months and may receive antibiotic treatment with ceftriaxone, followed by scheduled follow-ups with repeated tests and imaging to evaluate treatment response. Throughout the study, participants are regularly assessed with clinical exams, imaging, laboratory tests, and questionnaires to understand disease progression and immune response. The research team collects data on biological markers, develops new diagnostic tests, and monitors symptoms and treatment outcomes over time. Participants may be reevaluated at intervals of 6 to 12 months, contributing to a detailed database to guide future Lyme disease research and therapies.

Researchers are evaluating a culturally-tailored home-based physical activity program designed for Hispanic or LatinoLatina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects like weight gain, fatigue, and reduced physical fitness after cancer treatment. The study aims to see if this culturally-relevant program can help increase physical activity and improve overall health compared to using a Fitbit tracker alone. The study has two stages. In Stage 1, 20 Latinx survivors participate in developing the intervention using Fitbit trackers, text messages, social media support, wearable activity devices, and interviews over 9 months. In Stage 2, 170 survivors who do not meet physical activity guidelines are randomized to either the intervention group, which includes Fitbit use, weekly goal-setting, peer support via social media and Zoom meetings, and optional activity partners, or a control group that only uses Fitbit trackers for 12 weeks. The intervention includes an intensive phase with weekly sessions followed by a 4-week maintenance phase. Participants will wear Fitbit trackers daily and engage in goal-setting, peer discussions, and physical activity reminders. Researchers will measure moderate to vigorous physical activity, sedentary time, and health-related quality of life over 12 weeks. Additional evaluations include physiological markers of heart and metabolic health and qualitative interviews to improve the program. The study lasts through the intervention phases with ongoing monitoring and support for participants.

Researchers are evaluating the safety and tolerability of GIGA-564, a monoclonal antibody, in adults with locally advanced or metastatic solid tumor cancers that are either resistant to or have relapsed after prior systemic therapy. This Phase 1 study aims to find the highest dose that participants can tolerate and recommend the best dose for further studies. The study is sponsored by GigaGen, Inc. and focuses on advanced cancer types where other treatments have limited options. Participants will receive GIGA-564 through an intravenous infusion over at least 60 minutes on the first day of every 3-week cycle. During the dose escalation phase, up to five doses ranging from 0.3 to 20 mgkg will be tested sequentially, with treatment continuing for up to 4 cycles or until disease progression or unacceptable side effects occur. Following dose escalation, selected doses may be further studied in an expansion phase with similar treatment schedules and duration. Throughout the study, participants will be closely monitored for side effects and treatment reactions up to 154 days, including severe adverse events and toxicities during the first cycle. Researchers will also measure how the cancer responds according to RECIST criteria up to 24 weeks and assess longer-term outcomes such as progression-free survival and response duration for up to 2 years. Blood levels of GIGA-564 and its pharmacokinetics will be tracked to understand how the drug behaves in the body. Overall participation may last several months with detailed safety and efficacy evaluations.