Kettering

Researchers are collecting data from patients who undergo standard cardiac PET scans to better understand how the CardioFlux Magnetocardiography MCG device might help detect coronary ischemia. This observational registry includes participants with and without evidence of coronary ischemia on their cardiac PET scans to gather diagnostic information. The study is sponsored by Genetesis Inc. and focuses on patients suspected of myocardial ischemia. Participants will have previously completed a cardiac PET scan within two weeks before joining the study. The CardioFlux device, a magnetocardiography scanner paired with cloud processing software, will be used to record magnetic signals generated by the hearts electrical activity. The study groups include those with negative cardiac PET results and those with positive findings indicating ischemia. During the study, participants will be assessed using their standard cardiac PET data alongside CardioFlux MCG readings. The primary goal is to collect diagnostic data over 24 months to evaluate the potential use of the CardioFlux device in detecting coronary ischemia. Participants will be monitored for their ability to complete the procedure, including lying still for five minutes, and safety considerations related to implanted devices and health conditions are observed.

Researchers are evaluating the effectiveness and safety of combining calderasib with pembrolizumab as the first treatment for people with locally advanced or metastatic non-small cell lung cancer NSCLC that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. The study compares this combination to pembrolizumab with a placebo to see if it improves the time participants live without the cancer worsening and overall survival. Participants receive pembrolizumab through an intravenous infusion every 21 days for up to 35 cycles. They also take calderasib or a matching placebo by mouth daily until they meet criteria to stop treatment. The study is randomized and double-blind, meaning neither participants nor researchers know who receives calderasib or placebo. During the study, participants will have regular assessments to monitor cancer progression, overall survival, response rate, and quality of life measures through questionnaires. Safety will be closely monitored by tracking adverse events and treatment discontinuations. The study may last up to about 56 months, including follow-up to observe long-term outcomes and quality of life changes.

Researchers are evaluating the combination of pazopanib with or without abexinostat in patients who have locally advanced unresectable or metastatic renal cell carcinoma RCC. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare the effects of pazopanib plus abexinostat versus pazopanib plus placebo. The study focuses on progression-free survival and other outcomes to understand the potential benefits and risks of adding abexinostat to pazopanib treatment for this condition. Participants will be randomly assigned in a 21 ratio to receive either pazopanib plus abexinostat or pazopanib plus a placebo. Pazopanib is taken daily by mouth throughout each 28-day treatment cycle, while abexinostat or its matching placebo is taken twice daily on specific days within each cycle. If disease progression occurs, patients initially receiving placebo may switch to the combination of pazopanib plus abexinostat. Treatment continues until disease progression, unacceptable side effects, withdrawal, or study closure. Participants will undergo screening within 28 days before starting treatment to confirm eligibility. They will be monitored regularly during treatment cycles with assessments including imaging scans and evaluations of side effects using standard criteria. Outcome measures include progression-free survival, overall survival, response rates, duration of response, and changes in quality of life scores. Follow-up will continue for up to approximately four years, with ongoing safety and efficacy evaluations throughout the study period.

This research aims to evaluate the safety and effectiveness of neoadjuvant carboplatin combined with mirvetuximab soravtansine in women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha FR. Mirvetuximab soravtansine is an investigational antibody drug designed to selectively target and kill cancer cells carrying FR. The study enrolls about 140 adult female participants with stage III or IV disease across approximately 80 sites in the United States. Participants receive intravenous infusions of mirvetuximab soravtansine together with carboplatin on the first day of each 21-day cycle, for up to 6 to 9 cycles. Bevacizumab may also be given at the investigators discretion. This single-group study includes regular treatment cycles over a period lasting approximately three years. During the study, participants will have frequent visits to hospitals or clinics for medical assessments, blood tests, and scans to monitor their health and response to treatment. Researchers will measure outcomes including tumor response based on independent central review, adverse events, disease control, progression-free survival, and symptom changes. Safety and treatment effects will be tracked throughout the study duration of about three years.

Researchers are investigating new treatments for people with proficient mismatch repair pMMR endometrial cancer that is advanced or has returned after surgery. This cancer starts in the tissues inside the uterus and has spread locally or to other parts of the body, making it not removable by surgery. The study aims to learn if combining sacituzumab tirumotecan sac-TMT with pembrolizumab helps people live longer and without their cancer worsening compared to pembrolizumab alone. All participants first receive an Induction Phase of six cycles, each lasting three weeks, which includes pembrolizumab combined with carboplatin or cisplatin and paclitaxel or docetaxel. Those whose cancer does not progress then enter a Maintenance Treatment Phase and are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer progresses, participants may enter a Subsequent Treatment Phase where they are randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During maintenance and subsequent phases, sac-TMT is given on Days 1, 15, and 29 of each 6-week cycle, and pembrolizumab is given on Day 1 of each 6-week cycle. Participants are involved throughout the study, receiving intravenous treatments over several months and up to 14 maintenance cycles lasting about 19 months. Researchers will monitor cancer progression and survival up to approximately 44 to 54 months. They also assess safety by tracking adverse events and quality of life using questionnaires. The study requires regular visits for treatment and evaluation over this period to understand how well the treatments work and their effects on participants.

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

Researchers are conducting a randomized controlled trial to compare survival outcomes between robotic-assisted laparoscopy and open hysterectomy with lymph node assessment for early-stage cervical cancer. The study aims to determine if robotic hysterectomy with tumor containment before colpotomy is not worse than abdominal hysterectomy in terms of disease-free survival. It includes patients with specific cervical cancer stages and tumor sizes suitable for surgery. Participants will undergo either a radical or simple hysterectomy using either traditional open surgery or a robotic-assisted technique. In the robotic group, the vagina is closed before colpotomy, and certain vaginal manipulators are not allowed. Both groups may have salpingectomy and oophorectomy with or without ovarian transposition. Surgeons will document operative details, including any complications, blood loss, and reasons for conversion to open surgery. During the trial, participants will be closely monitored with preoperative assessments like labs, EKG, and MRI to confirm eligibility. Surgical findings and complications will be recorded. The primary outcome measured is survival at 36 months. Participants must provide informed consent and undergo follow-up to assess disease status and survival over the study period, which extends until 2030.

Researchers are evaluating the safety and effectiveness of the AlphaReturn Blood Management System used together with the AlphaVac Multipurpose Mechanical Aspiration MMA System for treating acute pulmonary embolism. This prospective, multicenter, single-arm study focuses on patients with acute intermediate-risk pulmonary embolism confirmed by computed tomography angiography CTA and specific clinical signs. The study aims to assess device-related adverse events and the technical success of the procedure. Participants will undergo mechanical thrombectomy using the AlphaVac MMA System. After the procedure, the aspirated blood will be filtered through the AlphaReturn Blood Management System and reinfused back into the patient. This investigational device study involves a single treatment group using these combined systems to manage blood during the intervention. During the study, participants will be closely monitored for device-related adverse events up to 30 days after the procedure. Additional assessments include tracking major adverse events, complications, symptomatic pulmonary embolism recurrence, reduction in right ventricle to left ventricle RVLV ratio, use of thrombolytics, and length of stay in intensive care and hospital. Safety and effectiveness outcomes will be collected throughout the follow-up period to evaluate the procedures impact and participant health.

Researchers are evaluating the efficacy and safety of lutetium 177Lu vipivotide tetraxetan AAA617 in adult men with oligometastatic prostate cancer OMPC that is progressing after initial treatment to the primary tumor. The goal is to control tumor recurrence and delay progression to fatal metastatic disease while preserving quality of life by postponing androgen deprivation therapy ADT. This is a Phase III, open-label study sponsored by Novartis Pharmaceuticals. Participants will receive stereotactic body radiation therapy SBRT to all metastatic prostate cancer lesions before starting treatment. Those in the investigational group will then receive up to four cycles of AAA617 every six weeks, with each cycle consisting of a dose of 7.4 GBq 200 mCi administered once. The control group will receive SBRT followed by observation without additional treatment. SBRT procedures last about three weeks, and treatment or observation continues until disease progression. Participants will undergo baseline assessments including PETCT scans with gallium 68Ga gozetotide or piflufolastat 18F, CT or MRI and bone scans. Follow-up visits occur weekly during weeks 1 and 3 of each treatment cycle and every 16 weeks thereafter until disease progression. Researchers will monitor metastasis-free survival, time to hormonal therapy, PSA progression, quality of life, pain, adverse events, and overall survival over approximately 6.5 years of study duration.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.