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Brain Neoplasms clinical trials

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NCT ID: NCT04755920 Recruiting - Clinical trials for Colorectal Neoplasms

SGM-101 in Colorectal Brain Metastases.

SGM-CBM
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

NCT ID: NCT04742231 Recruiting - Brain Tumor Clinical Trials

Handheld Dynamometer During Awake Craniotomy Pilot

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.

NCT ID: NCT04738162 Recruiting - Clinical trials for Brain Tumor, Pediatric

Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Supratentorial Brain Tumors

Start date: September 25, 2020
Phase: Phase 2
Study type: Interventional

In this prospective, open, single-armed, multicenter, phase II study for application of 5-ALA in children and adolescents with supratentorial brain tumors 80 patients will be investigated. Primary objective of the study is to determine the safety of 5-ALA for fluorescence-guided resections in children and adolescents with supratentorial, intra-axial brain tumors. Secondary objectives are - to determine whether fluorescent tissue truly signifies tumor (positive predictive value) in various pediatric brain tumors - to determine the degree of tumor resection on early post-operative MRI - and to determine the pharmacokinetics of 5-ALA in this population.

NCT ID: NCT04734444 Recruiting - Glioblastoma Clinical Trials

SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF). The performance will be assessed by analysis of the contrast-to-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale. This is a prospective, multi-centre single-arm study where the performance of SonoClear ACF relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of HGG and LGG at up to 10 sites will be included. Additionally, safety data are collected at 30 days and 6 months post-procedure.

NCT ID: NCT04722237 Recruiting - Quality of Life Clinical Trials

Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

ACT NOW
Start date: March 18, 2021
Phase: N/A
Study type: Interventional

Background. Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered Acceptance and Commitment Therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours. Aims. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among young brain tumour survivors. Method. This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control. Participants will be aged 11-24 years and survivors of brain tumours who have completed cancer treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The durability of treatment effects will be assessed by further follow-up assessments at 24-, 36- and 48- weeks. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically. Discussion. This study will provide an initial assessment of the value of remotely delivered ACT in supporting recovery and coping for young people after brain tumour treatment.

NCT ID: NCT04712721 Recruiting - Clinical trials for Glioblastoma Multiforme

Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.

Start date: October 14, 2021
Phase: Early Phase 1
Study type: Interventional

This is a First-In-Human (FIH) study of [68Ga]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of [68Ga]-FF58 in adults with relapsed or refractory (r/r) glioblastoma multiforme (GBM), breast cancer (BC) that has metastasized to the brain, gastroesophageal adenocarcinoma (GEA) or pancreatic ductal adenocarcinoma (PDAC) expected to overexpress alpha-v beta 3 (αvβ3) and alpha-v beta 5 (αvβ5) integrins.

NCT ID: NCT04712214 Recruiting - Glioma Clinical Trials

Use of Non-invasive Optical Analysis in Neurosurgery

Start date: March 28, 2021
Phase: N/A
Study type: Interventional

The present study aims to investigate the potential application of multispectral analysis, hyperspectral imaging, and fluorescence during neuro-oncological procedures, specifically during brain tumour debulking / resection. These optics techniques are entirely non-invasive and consist in camera with a filter to be linked to the standard microsurgical and endoscopic instruments used in theatre. The research procedure consists of images acquisition and data processing, with virtually no additional invasive procedures to be performed on patients.

NCT ID: NCT04711824 Recruiting - Breast Cancer Clinical Trials

Study of Stereotactic Radiosurgery With Olaparib Followed by Durvalumab and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases

SOLARA
Start date: March 9, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a Phase I/II study evaluating the safety and effectiveness of focused radiation therapy (radiosurgery) together with olaparib, followed by immunotherapy, for patients with brain metastases from triple negative or BRCA-mutated breast cancers. This study will have a Phase I portion in which subjects will be enrolled based on 3+3 dose escalation rules. Three dose levels of olaparib will be studied. Cycle 1 of study treatment will consist of Olaparib given twice daily concurrently with stereotactic radiosurgery (SRS). Olaparib will start one week prior to SRS and continue during and following SRS (1-5 fractions) for up to 28 days total. The number of doses of Olaparib will be dependent on how long it takes a subject to recover from SRS (ideally the subject will be off steroids, if they are required, at the start of Cycle 2, with exceptions outlined later in this section). Once the subject has recovered from SRS (based on investigator discretion) that will be considered the DLT period. Cycle 2 will be initiated with physician's choice systemic therapy and durvalumab. Cycle 2+ will equal 21 days. During Cycles 2 and 3, physician's choice systemic monotherapy will be given along with durvalumab per protocol. Each cycle will last 21 days. Imaging to evaluate intracranial and extracranial disease will be performed after Cycle 3, and subjects with response will continue with the systemic therapy and durvalumab until progression (intracranial or extracranial), unacceptable toxicity or death.

NCT ID: NCT04699773 Recruiting - Glioblastoma Clinical Trials

LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)

Start date: February 20, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.

NCT ID: NCT04692337 Recruiting - Brain Tumor Clinical Trials

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for brain tumor. The Ommaya reservoir will facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.