The purpose of this study is to assess the feasibility and safety of modified surgical eyeglasses to view bevonescein intraoperatively and the safety of bevonescein as it shows nerve tissue in the body. Bevonescein is an investigational drug being developed to help doctors identify nerves within the body during surgery.
The drug is administered through a vein in the arm and into the blood stream.t Bevonescein then travels through the blood where it makes nerve tissue fluorescent so that it can then be detected by the modified surgical eyeglasses used in this study by a surgeon. This may help the surgeon (study doctor) to tell the difference between nerve tissue and other tissue during surgery. Bevonescein and the modified surgical eyeglasses that your surgeon will wear (ReVealTM 475) are considered investigational because they are not approved by the Food and Drug Administration (FDA) to help with the visualization of nerves during surgery Alternatives to this study can include to undergo surgery without the study drug.
The duration of this study is about 2 months. The procedures of this study include administration of the study drug once (500 mg), collection of blood and urine samples, and ECGs. Surgery will happened as planned by the study doctor but as part of the research, the surgeon will ear modified surgical eyeglasses to view nerves and may take pictures or video clips. The glasses are FDA cleared but the modified filter and its use in combination with bevonescein is considered experimental.
The most commonly expected risks of fluorescein are nausea, vomiting, and stomach discomfort. Because bevonescein is cleared through the urine, there may be a potential risk to the kidneys and renal (kidney) system. The most serious risks of fluorescein may include severe local tissue damage, anaphylaxis, convulsions, cardiac arrest, and death.
The purpose of this study is to identify whether investigational blood and tissue testing can detect cancer cells in the blood stream can tell if subjects are responding to their individual treatment plans.
Participation will last as long as the subject's individual treatment plan and will consist of collecting tissue biopsies (10 slides), which will be taken during the subject's standard of care procedure, as well as blood draws (between 1 and 2 tablespoons), which will be taken during each of the subject's standard of care clinic appointments throughout their care journey.
The purpose of this research study is to see the impact of a study video on CRC screening rates and adherence.
Approximately 5,280 subjects will participate in this study at roughly 40 sites.
The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.
This is a clinical research study that is using an investigational product, 2X-121, as a possible treatment for diagnosed advanced solid tumors, both alone and in combination with another investigational product, dovitinib. Both drugs are taken orally and are also investigational, meaning that the FDA (the U.S. Food and Drug Administration) has not yet approved them as a treatment for any disease. The results of this study and previous studies will be used to design future studies to improve treatment of advanced solid tumors. This study will help determine the safety of 2X-121 and dovitinib. The study will help determine a safe and effective dose of 2X-121 alone and a safe and effective dose of dovitinib when given in combination with 2X-121. Subjects participating in this study will contribute to the development of a drug which has the potential to become a treatment option for them and others in the future. The expected duration of the study for participants is 24 months, this research study will involve two parts. Participants in Part 1 will be assigned to receive either 600 mg, 800 mg, or 1000 mg of 2X-121 daily for 28 days. Participants in Part 2 will be assigned to receive the chosen daily dose of 2X-121 as decided after Part 1, along with dovitinib at either a 300 mg, 400 mg, or 500 mg dose once daily for five days followed by 2 days without dovitinib. The 5 days on / 2 days off schedule will repeat for 28 days. Some reasonably foreseeable risks and discomforts include: Fatigue, Urine discoloration, diarrhea, nausea, vomiting, decreased appetite, rashes. It is hoped that the information gained from the study will help in the treatment of future patients with conditions like yours.
The Southeastern Consortium for Lung Cancer Health Equity (SC3), led by Dr. Robert A. Winn, assembles an outstanding interdisciplinary team of translational researchers positioned in the heart of the historical and current tobacco-producing region within the southeast. Collectively, SC3's investigative team has unparalleled experience in lung cancer screening, translational research in lung cancer health disparities, community outreach and engagement, and recruiting and retaining racial and ethnic minorities and individuals from other medically underserved groups using evidence-based strategies. As NCI-designated cancer centers, all three centers report high enrollment of underserved minorities onto interventional trials and are committed to reducing the substantial disparities found in lung cancer outcomes in their collective Black/African American and rural communities.
This research is being done to better understand how anti-cancer drugs affect cells within a tumor. Injecting very small amounts (microdoses) of pembrolizumab alone or in combination with MK-0482 or MK-4830 above may help the developer of these drugs to understand more about how these drugs work and what changes they make on the tumor. Subjects in this study will have their tumor injected with anti-cancer drugs using a CIVO device. The CIVO device delivers microdoses of multiple drugs or drug combinations directly into the tumor. Some of the procedures in this study include ultrasound assisted placement for tumor injection, a mucrodose injection of anti-cancer drugs into the tumor, and surgery to remove the tumor. Participation in the study will take 5 visits over a period if 56 days. The screening portion will be 28 days and the treatment portion will be 28 days from the time of the injection to the time of follow-up contact by the study team.
The purpose of this study is to learn about the effects of an experimental treatment called E7386. This study is for patients with hepatocellular carcinoma, colorectal cancer, endometrial cancer, or other solid tumors. E7386 in combination with levantinib fight tumors by decreasing tumor density. The purpose of this study is to learn about the effects of an experimental treatment called E7386. E7386 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease. Levantinib is FDA approved and has been previously used to treat cancer, however, it is considered experimental in combination with E7386.
The study is for patients that have been diagnosed with with a certain type of breast cancer, characterized as HER2 (Human Epidermal Growth Factor Receptor 2)-negative and hormonal receptor (HR)-positive, and with a specific characteristic (molecular subtype) called HeER2-Enriched. The investigational drugs used in this study are Ribociclib and Palbociclib. The main purpose of this study is to learn determine if participants with the specific HER2-Enriched subtype will have delayed progression of the disease when treated with ribociclib compared to palbociclib. Participants can expect to be in this study for up to 5 years.
This study is recruiting patients who have advanced non-small cell lung cancer (NSCLC) with a KRAS mutation whose cancer has not responded to standard of care treatment. (All human cells have a gene called KRAS. If cells have a KRAS mutation, the cells may multiply out of control which can cause cancer.) This study has two parts. The first part of the study is being done to find the safety, tolerability and safe dose of a study drug called BBP-398 when it is used in combination with another drug that has already been approved for use by the Food and Drug Administration, called Nivolumab. The second part of the study is being done to further understand the how tumors are affected by the study drug, BBP-398, and Nivolumab. About 26 patients in the United States will participate in this study. You may be eligible if you have NSCLC with a KRAS mutation that has not responded to standard treatment. Patients who enroll in this study will be required to come to MUSC for study treatments and follow-up visits. The participation in the study can last up to 2 years with a follow up period of 3 years.