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Brain Metastases clinical trials

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NCT ID: NCT06466720 Not yet recruiting - Quality of Life Clinical Trials

Measuring and Mapping Cognitive Decline After Brain Radiosurgery

CoDeB-Rad
Start date: June 10, 2024
Phase:
Study type: Observational

Background Stereotactic Radiosurgery (SRS) is a localised radiotherapy treatment for patients with brain metastases or other benign tumours in the brain, like meningiomas. We do not currently know if, or how much, SRS affects brain function. Patients with brain tumours do not get tested routinely for their brain function. Understanding short- and long-term side-effects is important for SRS. Brain metastases patients have short life expectancies (6-months to 1-year). However, meningioma patients can live 10 years or more. SRS is used to treat both. We will use the Montreal Cognitive Assessment (MoCA) to test your brain function. We will use quality-of-life questionnaires QLQ-C30 and BN20. These are specific for patients with brain cancer. They include questions about physical and mental wellbeing. Why is it important This study aims to identify areas in the brain that relate to changes in brain function after SRS. These areas can then have the radiation dose reduced to them in future patients, hoping to minimise side-effects. Research Question Which regions of the brain contribute to a decline in brain function following SRS. Study Design This is a single centre observational study with prospective and retrospective collection of data. This study will look at two groups of patients: Group1: Patients will complete the MoCA and two quality-of-life questionnaires before your treatment and every 3 months for a year. Group2: Patients will complete the MoCA and two quality-of-life questionnaires once. We will use these tests, your MRI scans and your SRS treatment plan to identify areas of the brain that are responsible for any problems with your brain function. The participants for Group 1 will be recruited from the SRS Clinics, at City Campus, Nottingham University Hospitals NHS Trust. The participants for Group 2 will be identified through the Mosaiq Oncology Information System. This pilot study is funded by the Midlands Mental Health and Neurosciences Network.

NCT ID: NCT06315010 Not yet recruiting - NSCLC Clinical Trials

REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis

REPOSE
Start date: August 2024
Phase: Phase 2
Study type: Interventional

REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene.

NCT ID: NCT06282874 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases.

NCT ID: NCT06101069 Not yet recruiting - Brain Tumor Clinical Trials

Development of MRF for Characterization of Brain Tumors After Radiotherapy

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study. The primary objectives of this study are: - To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage. - To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.

NCT ID: NCT06088056 Not yet recruiting - Breast Cancer Clinical Trials

A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases

Start date: November 2023
Phase: Phase 2
Study type: Interventional

This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases.

NCT ID: NCT06055790 Not yet recruiting - Brain Metastases Clinical Trials

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of care positive histology confirmation or confirmation MRI images. The main questions it aims to answer are: 1. What are the dynamics of 18F-Fluciclovine update within a non-treated metastatic brain lesion over 60 minutes? 2. What are the dynamics of 18F-fluciclovine update within recently treated metastatic brain lesions? 3. What is the potential use of 18F-Fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI? Participants will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesion(s). The study will characterize uptake dynamic PET images over 60 minutes. Uptake within the lesions and the benign brain parenchyma will be plotted on a time activity curve for 60 mins. Patients will undergo a second 18F-fluciclovine PET/CT to evaluate 18F-fluciclovine uptake in treated lesions over 60 minutes. This will be offered concurrently with the post-procedure standard of care (SOC) MRI to evaluate post-treatment changes. Uptake within the lesions and the benign brain parenchyma will be plotted on a 60 min time activity curve. Results will be compared to the pre-treatment baseline images. A third 18F-fluciclovine PET/CT will be offered to evaluate post radiation changes necrosis from recurrence, for up to 10 patients in our cohort who are under clinical surveillance (up to three years surveillance) and developed MRI evidence of either true progression or radionecrosis with clinical uncertainty after stereotactic radiosurgery. The initial 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. This will be compared to post procedural histological confirmation.

NCT ID: NCT06015295 Not yet recruiting - Brain Metastases Clinical Trials

A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy

Start date: February 28, 2024
Phase: N/A
Study type: Interventional

To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.

NCT ID: NCT05812534 Not yet recruiting - Clinical trials for Non Small Cell Lung Cancer

Study of Cadonilimab Combined With Bevacizumab and Chemotherapy for Advanced Nonsquamous Non-small Cell Lung Cancer Patients With Untreated Brain Metastases

CBC
Start date: December 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study was to investigate the efficacy and safety of Cadonilimab combined with bevacizumab and chemotherapy for advanced non-squamous NSCLC with untreated brain metastases. Cadonilimab is a bispecific antibody (BsAb), which can bind PD-1 and CTLA-4 at the same time with high affinity. It is a new tumor immunotherapy drug with tetravalent structure and short half-life. It has shown less toxicity than anti-PD-1 and anti-CTLA-4 antibodies in monkey toxicity studies. These characteristics make the application of Cadonilimab in tumor subjects may have better efficacy and safety. AK104-207 is an open, multicenter, phase Ib/II clinical study, which aims to evaluate the effectiveness and safety of Cadonilimab combined with chemotherapy as the first-line treatment for locally advanced or metastatic non-small cell lung cancer that cannot be operated and cannot receive radical concurrent/sequential radiotherapy and chemotherapy. As of August 1, 2022, 19 subjects who can evaluate non-squamous NSCLC (cohort B), ORR is 63.2%, DCR is 100%, median PFS is 13.34 months (7.36, NE), median OS is not reached, and 12-month OS rate is 76.0% (95% CI 48.0-90.3). In PD-L1 positive patients (n=9), ORR was 55.6% and DCR was 100%. In PD-L1 negative patients (n=7), ORR was 85.7% and DCR was 100%. In view of the early curative effect of Cadonilimab in NSCLC single drug or combination therapy and the encouraging research results of PD-1 inhibitor combined with CTLA-4 double immune combination therapy, it is expected that Cadonilimab combined with bevacizumab and chemotherapy will achieve good curative effect in NSCLC patients with brain metastasis.

NCT ID: NCT05807893 Not yet recruiting - Brain Metastases Clinical Trials

Study to Evaluate the Safety and Efficacy of Serplulimab Plus Bevacizumab and Chemotherapy in NSCLC Patients With Brain Metastases

SUPER BRAIN
Start date: April 14, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A multicenter, single-arm, open study to evaluate the safety and efficacy of Serplulimab in combination with bevacizumab and first-line chemotherapy in driver negative non-squamous NSCLC patients with brain metastases

NCT ID: NCT05737589 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Circulating Tumor DNA and T Cell Repertoire Predict Radiotherapeutic Outcomes in NSCLC Patients With Brain Metastasis

Start date: February 13, 2023
Phase:
Study type: Observational

Collection of ctDNA and TCR data to predict the efficacy and prognosis of brain radiotherapy in patients with brain metastases from non-small cell lung cancer (NSCLC) in a comprehensive manner