Spinal Tumor

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 machine learning-based approach to reduce surgical site infections (SSI) in patients undergoing brain or spinal tumor surgery. This study aims to validate whether using an intelligent prediction model to identify high-risk patients and applying tailored preventive measures can lower infection rates. It also assesses safety, hospital stay length, medical costs, and the model's practical feasibility. The study is a prospective, single-center clinical validation conducted at the Chinese Academy of Medical Sciences Cancer Hospital.

Researchers are studying spinal metastases, which are cancer spread to the spine, and evaluating whether adding an extra dose of radiation (called a radiation boost) to standard spine stereotactic body radiation therapy (SBRT) can better control tumors, reduce pain, and minimize long-term side effects. This is a Phase II trial sponsored by Sunnybrook Health Sciences Centre focused on improving outcomes for patients receiving radiation for spinal metastases. Participants receive a radiation boost targeted to the affected spinal area. The boost dose depends on the number of radiation treatment sessions normally prescribed; for example, if 2 sessions are planned, an additional 2 Gy is given, and similarly for 4 or 5 sessions. This boost is delivered along with the usual SBRT treatment. The study includes patients with spinal metastases who may have had surgery but no prior radiation to the treated spinal level. During the study, participants will be monitored for disease progression in the treated spine area for up to 12 months following radiation. Researchers will also assess pain levels at 3 and 6 months, side effects related to treatment, and spinal stability using specific scoring tools. Patients will complete pain and medication diaries and attend follow-up visits to track outcomes and safety. Treatment must begin within 14 days of radiation planning, and participants must be able and willing to complete the study activities.

Researchers are investigating the safety and effectiveness of Bevacizumab (BEV) with or without microbubble-mediated focused ultrasound (FUS) using the NaviFUS System in patients with recurrent glioblastoma multiforme (rGBM). This pivotal, randomized, open-label study compares standard care BEV alone to BEV combined with FUS in patients who have previously undergone surgery, radiotherapy, and chemotherapy with temozolomide. BEV is considered the best current treatment choice for these patients after prior therapies. Participants will be randomly assigned to one of two groups. One group will receive BEV alone via intravenous infusion at a dose of 10 mg/kg over 30-90 minutes every two weeks. The other group will receive the same BEV treatment followed by administration of microbubbles (SonoVue®) at 0.1 mL/kg and focused ultrasound exposure controlled by the NaviFUS System. Treatments will continue every two weeks for up to 34 weeks or until disease progression, intolerable side effects, non-compliance, or withdrawal. During the study, participants will be monitored through regular assessments including MRI scans, quality of life questionnaires, cognitive tests (Mini-Mental State Examination), and evaluation of corticosteroid use and adverse events. The primary outcome is progression-free survival at six months. Secondary outcomes include survival rates up to two years, tumor response, local disease control, and performance status. The total study participation can last up to 36 months with ongoing safety and efficacy monitoring.

Spinal cord gliomas are rare malignant tumors that develop within the spinal cord, often appearing around age 35 and slightly more common in males. These tumors typically cause symptoms like axial pain and tend to grow in a lateral, infiltrative pattern. Treatments are limited mainly to surgery, and the choice of surgical approach can affect neurological outcomes and quality of life. This research compares two surgical methods to find the best approach for tumor removal and patient recovery. The study compares the dorsolateral sulcus (DLS) approach and the traditional posterior median sulcus (PMS) approach for spinal cord tumor removal. The DLS approach is thought to better preserve neurological function by avoiding critical midline structures, while the PMS approach offers direct midline access but risks more damage. Patients with laterally located tumors, confirmed by imaging and pathology, undergo surgery via one of these two methods. Outcomes will be assessed over time to evaluate pain, neurological function, quality of life, tumor removal extent, and survival. Participants will be evaluated before surgery and followed up at 1, 3, 6, and 12 months after surgery with clinical exams, imaging, and questionnaires like the Visual Analog Scale for pain and SF-36 for quality of life. Neurological function is measured using established grading scales, and tumor progression and survival are monitored up to 24 and 36 months, respectively. The study aims to determine which surgical approach best balances effective tumor removal with preservation of neurological health.

Researchers are evaluating the safety of avutometinib as a treatment for children and young adults aged 3 to 30 years with advanced or recurrent solid tumor cancers, including pediatric tumors with specific genetic alterations affecting the MAP kinase pathway and certain neurofibromatosis conditions. This phase 1 study aims to find the highest dose of avutometinib that is safe and causes few or mild side effects. Participants receive oral avutometinib twice a week, once daily, in cycles of three weeks on treatment followed by one week off, with each cycle lasting 28 days. The study uses a dose-escalation design, starting at Dose Level 1 and adjusting the dose based on the number of dose-limiting toxicities (DLTs) observed, to identify the maximum tolerated dose (MTD). During the study, participants will be closely monitored for safety over up to 12 months. Researchers will assess side effects and tolerability, and participants will undergo regular evaluations including clinical assessments and laboratory tests. The study carefully tracks adverse events and adjusts dosing to ensure participant safety throughout the trial.

Researchers are evaluating whether mirdametinib is a safe and effective treatment for Central Nervous System tumors, including glioma and neurohistiocytosis. This phase 1/2 trial focuses on patients with MAPK pathway mutant CNS tumors to better understand the drug's impact on these conditions. The study is sponsored by Memorial Sloan Kettering Cancer Center and aims to measure the best overall neurologic response rate within one year. Participants are divided into two main groups. Eleven patients with refractory neurohistiocytosis will receive continuous cycles of mirdametinib. Meanwhile, 30 participants with recurrent NF1-mutant glioma will be randomized in a 2:1 ratio to either receive perioperative mirdametinib for five days before surgery or no drug before surgery. After surgery, all glioma participants will take mirdametinib twice daily continuously until disease progression or clinical changes occur. During the study, participants will undergo regular evaluations including neurological assessments and monitoring of disease progression via imaging scans. Researchers will collect data on safety, tolerability, and treatment response. The study includes scheduled visits, laboratory tests, and performance status assessments. Participation will continue until disease progression or other criteria require stopping treatment, with ongoing monitoring throughout the trial period.

Researchers are evaluating PHST001, an anti-CD24 macrophage checkpoint inhibitor, in adults with advanced relapsed or refractory solid tumors. This multi-center, first-in-human Phase 1a/1b study aims to assess the safety, how the drug moves and works in the body, and its antitumor activity. Phase 1a focuses on PHST001 alone, including some central nervous system tumors, while Phase 1b studies PHST001 combined with chemotherapy in ovarian, endometrial, and cholangiocarcinoma cancers. PHST001 is given as intravenous infusions every three weeks. In Phase 1a, nine dose levels of PHST001 monotherapy will be tested to find the recommended dose for Phase 2. In Phase 1b, participants receive PHST001 combined with standard chemotherapy drugs, including paclitaxel, topotecan, doxorubicin, FOLFIRI, FOLFOX, or gemcitabine. After safety is confirmed in initial groups, additional participants will join tumor-specific expansion groups at a fixed dose. Participants will be monitored for side effects, treatment response, and drug levels through regular visits up to two years. Safety assessments include tracking dose-limiting toxicities, serious adverse events, and treatment-related side effects from the first dose through 90 days after the last dose. Antitumor activity will be measured using imaging criteria like RECIST v1.1 or RANO for CNS tumors. Pharmacokinetic studies will characterize how PHST001 behaves in the body during and after treatment.

Researchers are evaluating a new way to provide preoperative information to patients who are candidates for spinal or urological surgery. This study is an interventional, randomized controlled trial conducted at multiple centers. It aims to compare a new multimedia-based method that objectively checks patient understanding against the standard informed consent process to see which better supports patient decision-making about surgery. Participants in the experimental group will receive detailed information through videos with surgical options, graphics, and animations. They will also have interviews with the surgeon and caregivers using 3D-printed models to guide shared decision-making. After deciding on surgery, patients will join educational programs to reinforce understanding before a final surgeon interview and signing of informed consent. The control group will receive the usual care, including a standard explanatory interview and consent signing. Throughout the study, participants will complete questionnaires assessing satisfaction, comprehension, mental health, pain, disability, urinary and sexual function, and legal outcomes at multiple time points: before surgery, at discharge, and at two and six months after surgery. The research team will monitor these measures to evaluate the impact of the new method on patient understanding and decision satisfaction over time.

Researchers are investigating a new treatment approach for pediatric and young adult patients with relapsed or refractory solid tumors. The study focuses on using allogeneic stem cell transplantation that removes alpha/beta T cells and CD19+ B cells to reduce complications like graft-versus-host disease and improve outcomes. This approach is combined with zoledronic acid to potentially enhance the immune system's ability to fight tumors and improve survival rates. Participants will receive a stem cell transplant processed with the Miltenyi CliniMACS Prodigy® system to remove specific immune cells. Zoledronic acid will be given intravenously on days 28, 56, 84, 112, and 140 after transplant. The study includes a phase Ib dose-finding segment and a phase II segment to evaluate the safest and most effective dose of zoledronic acid. During the study, participants will be closely monitored for disease-free survival at 1 year post-transplant and the incidence of acute graft-versus-host disease over 2 years. Additional survival rates will be assessed at 100 days, 1 year, and 2 years. Assessments include clinical evaluations and safety monitoring over several years, with the total participation lasting until 2 years post-transplant to evaluate long-term effects and outcomes.