Spinal Tumor

Researchers are evaluating the use of Gallium-68-DOTATATE PETMRI 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 models 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 mgkg 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 mLkg 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 whether mirdametinib is a safe and effective treatment for Central Nervous System tumors, including glioma and neurohistiocytosis. This phase 12 trial focuses on patients with MAPK pathway mutant CNS tumors to better understand the drugs 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 21 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, for its safety, pharmacokinetics, pharmacodynamics, and antitumor activity in adults with advanced relapsed or refractory solid tumors. This Phase 1a1b open-label study includes participants with various solid tumors, including CNS tumors in Phase 1a, and focuses on ovarian, endometrial, and cholangiocarcinoma cancers in Phase 1b. The study aims to determine the recommended Phase 2 dose and assess safety and tolerability of PHST001 alone and combined with chemotherapy. PHST001 is given as intravenous infusions every three weeks. In Phase 1a, nine escalating dose levels will be tested as monotherapy. Phase 1b includes combination treatments with chemotherapy drugs such as paclitaxel, topotecan, doxorubicin, FOLFIRI, FOLFOX, and gemcitabine. The study has a safety run-in phase followed by tumor-specific expansion cohorts at a fixed PHST001 dose combined with chemotherapy. Participants will undergo screening and receive study treatment with ongoing safety monitoring. Researchers will assess dose-limiting toxicities, adverse events, and antitumor activity using RECIST or RANO criteria over up to two years. Pharmacokinetic parameters of PHST001 will also be measured. Safety will be observed up to 90 days after the last dose. The total participation duration varies based on treatment and follow-up.

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 treatment for children, adolescents, and young adults with relapsed or refractory solid tumors. The study evaluates the safety and potential survival benefits of an allogeneic stem cell transplant depleted of alphabeta T cells and CD19 B cells combined with zoledronic acid. This approach aims to enhance the immune systems graft versus tumor effect and improve event-free and overall survival rates in these patients. Participants receive a stem cell transplant processed using the Miltenyi CliniMACS Prodigy system to remove specific immune cells. Zoledronic acid is given intravenously on days 28, 56, 84, 112, and 140 post-transplant. The study includes a phase Ib dose-finding portion to determine the maximum tolerated dose of zoledronic acid, followed by a phase II portion where all subjects receive this dose. During the trial, participants are closely monitored through various assessments including disease-free survival and incidence of acute graft-versus-host disease at multiple time points up to two years after transplant. The research team evaluates overall survival rates at 100 days, 1 year, and 2 years post-transplant. The study spans several years, with participants undergoing treatment and follow-up evaluations to track safety and effectiveness.

Researchers are evaluating proton therapy in patients with chordoma, chondrosarcoma, Ewing sarcoma, and osteosarcoma who require two radiation beams for treatment. This study aims to compare the toxicity of proton therapy delivered using a single daily beam versus the conventional approach of two daily beams. The latest ProteusOne proton therapy equipment with a compact rotating gantry enables precise targeting of tumors from different angles, potentially reducing treatment side effects. Participants are randomly assigned to receive either one daily beam, which delivers a doubled dose in each session, or two daily beams delivered according to the standard treatment plan. Both beams are conventionally delivered in the same session but require repositioning the patient before each beam, which takes extra time. This study evaluates whether delivering only one beam daily can maintain treatment effectiveness while reducing toxicity and saving time over the 2 to 7 week treatment period. During the treatment and up to five years of follow-up, patients will be monitored for side effects, quality of life, and treatment effectiveness. Researchers will measure the frequency of toxicities and assess quality of life throughout treatment and follow-up. They will also evaluate the time saved by using a single daily beam. The total participant involvement includes initial treatment and long-term follow-up visits to assess outcomes and safety.