Brain Cancer

Researchers are evaluating the safety and appropriate dose of increasing levels of the radioactive drug 131I-TLX101, given by intravenous infusion, combined with the best standard care in adults newly diagnosed with glioblastoma, a type of brain cancer. This open-label, single-arm study is conducted across multiple centers and aims to understand how patients tolerate this treatment alongside standard therapies. Participants receive escalating doses of 131I-TLX101 through an intravenous infusion along with the standard chemoradiation therapy known as the Stupp regimen, beginning 3 to 6 weeks after surgical removal of the tumor. The study includes a dose-finding phase to establish the recommended dose, with safety monitored throughout. The radioactive drug is administered in ascending doses, and the study observes participants for up to 62 weeks. During the study, participants will undergo regular safety assessments including laboratory tests of liver and kidney function, monitoring for adverse events, and evaluations of treatment-related toxicities for up to 62 weeks. Researchers will track the incidence and severity of dose-limiting toxicities and treatment-emergent adverse events. Participants must comply with radiation safety guidelines and attend scheduled visits for monitoring. The total study duration from screening until the end is about 62 weeks.

Researchers are evaluating new treatment options for meningiomas that continue to grow despite prior local therapies like surgery and radiotherapy. This study focuses on a precision medicine approach combining diagnostic patient selection with PET molecular imaging and a targeted systemic radioligand therapy called [177Lu]Lu-DOTATATE. This is the first randomized trial investigating this therapy in patients with refractory meningioma, aiming to open new avenues for treatment and research in this area. Participants are randomly assigned to receive either the experimental therapy with intravenous [177Lu]Lu-DOTATATE at a dose of 7.4 GBq every four weeks for four cycles or a control group receiving local standard care as decided by their physician. The control treatments may include hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or no treatment with observation and supportive care. This randomized Phase II study compares the impact of these approaches on meningioma progression. During the study, participants will undergo regular assessments including MRI scans, PET imaging, neurological function evaluations using the NANO scale, and health-related quality of life questionnaires. Researchers will monitor disease progression, survival, radiological response, and treatment side effects up to two years after enrollment. Liver, kidney, blood, and electrolyte function are also checked before treatment. Participants will be followed closely to evaluate the treatment's effect and safety throughout the study period.

Researchers are evaluating the optimization of 18F-DOPA PET/CT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinson's disease or Lewy body dementia. The study aims to improve image quality using a new digital PET/CT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PET/CT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

Researchers are evaluating new imaging techniques to better detect tumors in people with brain metastasis. This study focuses on comparing positron emission tomography (PET) combined with magnetic resonance imaging (MRI) against other imaging methods to determine if these newer techniques can more accurately identify cancerous tissue. Improved imaging is important to help locate tumors and guide future cancer treatments. Participants will undergo a single PET/MRI scan using a radiotracer called F-Fluciclovine, followed by a separate MRI scan with a tracer. These imaging methods are performed on the same machine that creates detailed pictures using magnets and radio waves. The PET and MRI scans assess protein levels in tumor tissue, with higher protein levels suggesting tumor presence rather than normal brain tissue. During the study visit, which lasts about three hours, participants will be asked to lie still for 30 to 60 minutes during imaging. Researchers will measure amino acid uptake into tumor tissue to compare imaging results. Patients must be able to complete the scans without requiring intravenous sedation, and medication use for mild anxiety is allowed under specific conditions. All scans and procedures are conducted to monitor tumor presence and treatment changes safely.

Researchers are evaluating the use of 18F-Fluciclovine positron emission tomography (PET) as a biomarker to measure the response or progression of brain metastasis in participants treated with stereotactic radiosurgery (SRS). This pilot imaging study focuses on adults diagnosed with brain metastases who are planned to receive SRS treatment. The study is sponsored by Baptist Health South Florida and is a Phase 1 clinical trial. Participants will undergo an 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). They will then receive a single dose of SRS as part of their standard care. A second 18F-fluciclovine PET scan will be performed approximately 8 weeks after the SRS treatment, with a window of plus or minus 2 weeks. During PET scans, participants receive a 5-mCi dose of 18F-fluciclovine through intravenous injection, with imaging data collected up to 25 minutes post-injection. Throughout the study, participants will be monitored using PET imaging to evaluate changes in standardized uptake values (SUV) over 8 weeks, which helps assess tumor response. Tumor control will also be evaluated at 12 months. The study involves standard imaging, including MRI and PET scans, and tracks participant safety and treatment progress. Total participation timelines include initial scans at SRS planning and follow-up imaging about 8 weeks later, with tumor control assessed after one year.

Researchers are evaluating whether 18F-fluciclovine (Axumin®) PET imaging can help doctors distinguish between true tumor growth and other changes in children with high-grade gliomas, including diffuse midline glioma. This distinction is important because true tumor progression may require a change in treatment, while post-treatment changes usually do not. Conventional MRI scans cannot reliably make this differentiation, so this study aims to see if 18F-fluciclovine PET imaging can serve as a useful diagnostic tool. Participants will receive a single intravenous injection of 18F-fluciclovine before undergoing a combined PET-MRI scan. This imaging process is designed to assess tumor status by detecting physiological changes. The study focuses on children and young adults aged 1 to under 21 years with measurable high-grade gliomas or diffuse midline gliomas. The study is an early phase 1 trial, and treatment involves only this one-time imaging procedure. During the study, researchers will analyze the imaging results and compare them to histopathology findings within four weeks and evaluate safety over six months. Participants will be monitored for any side effects related to the imaging agent. The study will assess the usefulness and safety of 18F-fluciclovine PET-MRI in guiding treatment decisions for pediatric high-grade glioma. Participation lasts through these assessments, with imaging and follow-up evaluations scheduled accordingly.

Researchers are studying the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging in patients with cancer. This phase I trial aims to evaluate how well FLT PET imaging measures tumor growth and the activity of the DNA synthetic pathway in various cancers, including solid tumors and blood cancers. The study also seeks to determine how effective this imaging method is at detecting lesions and assessing response to treatment. Participants receive up to four FLT PET imaging procedures. During each procedure, a small amount of the FLT tracer compound is injected into the vein, followed by PET scan data collection for two hours to measure tumor growth. Blood samples may be taken during the scans, and urine samples collected afterward to analyze breakdown products of the tracer. Throughout the study, patients undergo assessments including PET or CT PET scans to measure tracer uptake and retention in tumors and normal organs. Researchers also evaluate changes in key enzymes related to DNA synthesis before and after therapy. These evaluations help monitor tumor activity and treatment response. The total time participants spend in the scanner during imaging is up to two hours per session, with a focus on capturing detailed tumor growth information.

Meningiomas are the most common primary intracranial tumors and are often surgically resectable. However, the intraoperative texture and adhesion of the tumor to surrounding structures vary widely and directly impact the surgical approach, difficulty, and outcomes. Current preoperative imaging lacks the ability to quantitatively assess biomechanical properties such as stiffness and adhesion, which are critical for neurosurgical planning. This prospective clinical trial investigates the application of 3D magnetic resonance elastography (MRE) in characterizing the biomechanical properties of meningiomas. Specifically, it aims to quantify tumor stiffness and adhesion using MRE-derived shear modulus maps and correlate these measurements with intraoperative surgeon-assessed stiffness/adhesion scores and postoperative histopathology. The study will also assess the diagnostic performance of MRE in predicting challenging resections, high tumor adhesion, and histological subtypes. Approximately 300 patients with radiologically confirmed meningioma scheduled for elective resection will be enrolled. Participants will undergo standard MRI and additional 3D MRE scanning. Intraoperative findings including tumor stiffness, adhesion, blood supply, and resection difficulty will be systematically recorded. Postoperative pathological analysis will include tumor grade and histological subtype. Statistical analyses will evaluate correlations, diagnostic accuracy, and potential prognostic value. Findings from this study may support the use of 3D MRE as a valuable noninvasive tool in preoperative assessment of meningiomas, helping optimize surgical strategies, reduce complications, and inform treatment decisions.

Researchers are evaluating the safety and tolerability of amivantamab, an investigational drug, in patients with high grade malignant brain tumours such as glioblastoma. This Phase 1b trial focuses on a biomarker-defined group of patients whose tumours show EGFR amplification. The study aims to determine the preliminary anti-tumour activity of amivantamab administered at the recommended Phase 2 dose, with decisions guided by adaptive trial design and safety review committees. Amivantamab will be given by intravenous infusion weekly for the first 4 weeks, then every 2 weeks thereafter until the disease progresses or unacceptable side effects occur. The initial dose is split over two days, with subsequent doses given over 2 to 5 hours initially and shorter infusions if well tolerated. This Phase 1b biomarker arm will enroll 12 patients with relapsed glioblastoma to assess treatment effects. Participants will undergo regular monitoring including whole genome and transcriptome data collection as part of the Minderoo Precision Brain Tumour Programme. Safety and tumour response will be closely assessed through clinical evaluations and imaging over an 18-month period. The main outcomes measured are safety, tolerability, and preliminary anti-tumour activity, with additional analysis of molecular markers related to treatment response.

Researchers are evaluating the safety, tolerability, and preliminary antitumor activity of paxalisib combined with temozolomide in patients with high-grade malignant brain tumors, including glioblastoma. This Phase 1b and Phase 2 study is part of the 5G-PEARL trial, which uses biomarker-guided approaches to treat tumors with specific genetic changes such as PI3K mutations or PTEN loss. The study aims to test these treatments in molecularly defined patient groups to better understand their effects. The study includes two parts: Phase 1b focuses on safety and early activity, while Phase 2 assesses effectiveness further. In Phase 1b, patients receive paxalisib starting at 45 mg once daily, with a possible increase to 60 mg per day in Cycle 2. Temozolomide is taken orally once daily on days 1 to 5 of each 28-day cycle, starting at 150 mg/m2 with potential dose increase to 200 mg/m2 from Cycle 3 if tolerated. The trial enrolls patients into two biomarker arms based on tumor genetics, with adaptive decision points to guide study progress. Participants will have assessments including safety monitoring and genetic biomarker analysis over up to two years, depending on the phase. Researchers measure treatment-emergent adverse events and antitumor activity as primary outcomes. Quality of life and additional biomarker responses are also evaluated. Patients will be monitored regularly through clinical visits and tests to track treatment effects and side effects throughout the study duration.