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Brain Metastases clinical trials

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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: NCT06072807 Recruiting - Breast Cancer Clinical Trials

Brain [18F]-FES PET/CT in Patients With Estrogen-Receptor Positive Breast Cancer

Start date: December 27, 2023
Phase: Phase 4
Study type: Interventional

The goal of this interventional study is to optimize the protocol of FES PET/CT in Estrogen Receptor positive Breast cancer patients with Brain metastases. Patients will undergo MRI of the brain and FDG PET/CT brain as part of standard of care for radiation treatment planning. An additional 18F-FES PET/CT brain scan will be completed before this standard of care radiation treatment. Patients will be followed prospectively with clinical and MRI assessments per standard-of-care for a total of 12 months. Study Population: Patients with ER-positive breast cancer with biopsy proven or suspected new or recurrent brain metastases (based on standard of care MRI) planned for radiation treatment of brain lesions.

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

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

Start date: April 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: NCT06048094 Recruiting - Brain Metastases Clinical Trials

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

FACILITATE
Start date: April 11, 2024
Phase: Phase 1
Study type: Interventional

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

NCT ID: NCT06045065 Recruiting - Brain Metastases Clinical Trials

Preclinical Brain Tumor Models

HITCH
Start date: January 2, 2022
Phase:
Study type: Observational

Background: Primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. Thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. At the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. However, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies. In this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic. Objective: Our goal will be to generate tumoroids and stem-like cell lines (PDX) from patient tumor samples. Methods: We will establish tumor tumoroids and stem cell lines from patient samples. These preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3R). Overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.

NCT ID: NCT06020066 Recruiting - Clinical trials for Non-small Cell Lung Cancer

SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI

Start date: August 10, 2023
Phase: Phase 2
Study type: Interventional

Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.

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: NCT05996432 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy

Start date: May 17, 2023
Phase: Early Phase 1
Study type: Interventional

This study will apply novel MRI approaches with established sensitivity to tissue oxygen consumption and perfusion to predict hypoxia-associated radiation resistance, manifested as tumor recurrence and progression post-treatment.

NCT ID: NCT05987644 Recruiting - Lung Cancer Clinical Trials

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements

DURABLE
Start date: March 7, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib. A maximum of 25 cycles (2 years) of alectinib may be administered on study.

NCT ID: NCT05977803 Recruiting - Brain Metastases Clinical Trials

Contribution of the CEST Sequence in the Characterization of Radionecrosis of Brain Metastases of Pulmonary Origin

ACROP
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to determine whether the use of the CEST sequence would have diagnostic performance equivalent to the reference method of T2* infusion with contrast injection in the diagnosis of radionecrosis of lung cancer brain metastases.