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Monthly Update Report for Trials Started in December 2025


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1: Summary data from new trials identified for Brain Cancer.


Overview

Number of Trials: 15

These 15 trials focus on brain tumors and brain metastases, spanning pediatric and adult populations. Interventions include novel imaging agents (5-ALA, fluciclovine F-18, MeFAMP), advanced surgical techniques (MRI-guided resection, LITT, GammaTile), radiation modalities (hippocampal/memory avoidance WBRT, stereotactic radiosurgery), and experimental systemic therapies (AMXT 1501, ruxolitinib, oncolytic HSV-1 M032). Several trials test cognitive rehabilitation, active surveillance for brain metastases, and perioperative steroid management. Common tumor types include glioblastoma, diffuse midline glioma, low-grade glioma, neuroblastoma, sarcomas, and brain metastases from solid tumors.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years (adult trials) or specific pediatric age ranges
  • Histologically or radiographically confirmed brain tumor or metastasis
  • Karnofsky or Lansky performance status ≥50-70
  • Adequate organ function (liver, renal, bone marrow)
  • Ability to provide informed consent or assent
  • Life expectancy >3-12 weeks
  • Measurable disease on MRI
  • Ability to undergo MRI with contrast

Common Exclusion

  • Pregnancy or breastfeeding
  • Active uncontrolled infection
  • Contraindications to MRI
  • Prior treatment for same tumor (varies by trial)
  • Concurrent investigational agents
  • Severe cardiac, renal, or hepatic dysfunction
  • Psychiatric or social conditions limiting compliance
  • Leptomeningeal disease (select trials)
  • Concurrent malignancy (unless disease-free ≥3 years)

2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06907485

A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration

Organization/Sponsor: University of Pittsburgh


Example patient: A 9-year-old male with MRI-confirmed recurrent pilocytic astrocytoma requiring surgical resection, normal blood counts and organ function, no history of porphyria, and able to swallow oral medication.

Phase N/A

Interventions

  • Drug: Aminolevulinic acid hydrochloride
    Summary: A metabolic pro-drug converted to protoporphyrin IX that accumulates in tumor cells and fluoresces under specific light wavelengths, enabling visualization during surgical resection of brain tumors (FDA label, NCI Thesaurus).

Key Inclusion

  • MRI-documented new or recurrent primary pediatric brain tumor requiring resection
  • Age 2-17 years and 182 days
  • Anticipated histology includes pilocytic astrocytoma, PXA, ganglioglioma, DNET, astrocytoma, oligodendroglioma, ependymoma, PNET, ATRT, or medulloblastoma
  • Normal organ and marrow function with leukocytes >3,000/mL and platelets >100,000/mL
  • Ability to swallow 5-ALA solution
  • Negative pregnancy test for females of childbearing potential

Key Exclusion

  • Unable to swallow 5-ALA solution
  • Radiographic tumors of the brain stem on MRI
  • History of allergic reactions to 5-ALA or similar compounds
  • Personal or family history of porphyria
  • Pregnant or breastfeeding
  • Prior history of GI perforation, diverticulitis, or peptic ulcer disease
  • Uncontrolled infection or psychiatric illness limiting compliance

NCT06455189

Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 52-year-old adult with newly diagnosed glioblastoma measuring 4.5 cm on MRI with peritumoral FLAIR abnormality, no prior brain tumor treatment, and eligible for gross total resection.

Phase N/A

Interventions

  • Procedure: MRF/MRI infiltration guidance for extended resection
    Summary: An imaging modality used to direct therapeutic intervention, specifically using magnetic resonance fingerprinting to guide extended surgical resection beyond standard boundaries in glioblastoma (NCI Thesaurus).
  • Procedure: Control Group - Standard of care neurosurgical resection
    Summary: Standard comparison group receiving conventional neurosurgical resection without advanced MRF imaging guidance (NCI Thesaurus).

Key Inclusion

  • Age > 18
  • MR imaging findings suggestive of glioblastoma
  • Maximal tumor diameter greater than 3 cm
  • Ability to provide written informed consent
  • Ability to undergo MRI scan
  • Stage II: Lesions amenable to gross total resection
  • Stage II: Presence of peritumoral FLAIR signal abnormality beyond enhancement area

Key Exclusion

  • Contraindications to MRI
  • Contraindication to surgical treatment
  • Prior treatment for glioblastoma
  • Stage II: Undergoing only stereotactic biopsy or less than gross total resection
  • Stage II: Undergoing LITT
  • Previously treated or recurrent glioma

NCT07248228

A Randomized Phase 2 Trial of Memory Avoidance Whole Brain Radiotherapy Versus Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking woman with metastatic lung cancer and 12 brain metastases, KPS 80, no prior brain radiation, and lesions located outside hippocampal regions.

Phase 2

Interventions

  • Drug: Memantine
    Summary: NMDA receptor antagonist that blocks glutamate-mediated excitotoxicity to preserve cognitive function, indicated for moderate to severe Alzheimer's dementia; used here to potentially protect cognition during brain radiation (FDA label, NCI Thesaurus).
  • Radiation: HA-WBRT (Hippocampal Avoidance Whole Brain Radiation Therapy)
    Summary: Intensity-modulated whole-brain radiation therapy that reduces radiation dose to the hippocampus to preserve memory function during treatment of brain metastases (NCI Thesaurus).
  • Radiation: MA-WBRT (Memory Avoidance Whole Brain Radiation Therapy)
    Summary: Intensity-modulated whole-brain radiation therapy that reduces radiation dose to memory-related brain structures including hippocampus to preserve cognitive function during treatment of brain metastases (NCI Thesaurus).

Key Inclusion

  • Solid tumor with brain metastases confirmed histologically, cytologically, or radiographically
  • Age greater than 18 years
  • Karnofsky Performance Status at least 70
  • Life expectancy at least 3 months
  • Candidate for whole brain radiation therapy
  • Primary English speaker
  • At least 10 brain metastases or suitable for WBRT

Key Exclusion

  • Prior whole brain radiation
  • Multiple Sclerosis, Alzheimer's, dementia, or mental disability
  • Pregnant or breastfeeding
  • Unable to receive MRI
  • Metastasis within neurocognitive avoidance structures (hippocampus, amygdala, fornix, corpus callosum, pituitary)

NCT05555550

Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)

Organization/Sponsor: Children's Hospital of Philadelphia


Example patient: A 9-year-old child with biopsy-confirmed WHO grade II supratentorial glioma measuring 2x2 cm on MRI, Lansky score of 70, normal kidney function, weighing 25 kg, about to start chemotherapy.

Phase N/A

Interventions

  • Diagnostic Agent: 18F-Fluciclovine
    Summary: A fluorine-18 radiolabeled synthetic L-leucine analogue that enters cells via L-type amino acid transporters and accumulates in tumor cells due to increased metabolic needs without being metabolized, enabling PET imaging of tumors (FDA label, NCI Thesaurus).

Key Inclusion

  • Low grade glioma WHO grade I-II brainstem or supratentorial
  • Evaluable disease at least 1x1 cm on MRI
  • Scheduled to receive systemic therapy for LGG
  • Karnofsky ≥50 if >16 years or Lansky ≥50 if ≤16 years
  • Age ≥1 and ≤21 years at registration

Key Exclusion

  • Inability to tolerate imaging procedures
  • Pregnant participants
  • Weight less than 8 kg
  • Cannot avoid contact with pregnant women or infants for 12 hours post-injection
  • Abnormal kidney function or creatinine ≥CTCAE grade 2
  • Primary spinal cord tumors

NCT06465199

A Dose Escalation Study Using Eflornithine (DFMO) and AMXT 1501 Followed by a Randomized Controlled Trial of DFMO With or Without AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas

Organization/Sponsor: Milton S. Hershey Medical Center


Example patient: A 15-year-old with relapsed high-risk neuroblastoma after multi-agent chemotherapy, currently stable on salvage therapy with measurable disease <2 cm, performance score 70, and adequate cardiac and renal function.

Phase 1, Phase 2

Interventions

  • Drug: AMXT 1501 Dicaprate
    Summary: Orally bioavailable polyamine transport inhibitor that blocks polyamine uptake into tumor cells, reducing intratumoral polyamine concentrations to inhibit proliferation, induce apoptosis, and reverse immune suppression in the tumor microenvironment (NCI Thesaurus).
  • Drug: Eflornithine (DFMO)
    Summary: Irreversible ornithine decarboxylase inhibitor that blocks polyamine biosynthesis, inhibiting tumor cell formation and proliferation, and inducing apoptosis (NCI Thesaurus).

Key Inclusion

  • Age ≤21 years at diagnosis
  • Relapsed/refractory neuroblastoma, ETMR, ATRT, Ewing sarcoma, or osteosarcoma; or newly diagnosed DIPG
  • DIPG subjects must start >30 and ≤60 days after standard radiation therapy
  • Lansky or Karnofsky Performance Scale ≥60
  • Adequate organ function: ANC ≥750/μL, normal cardiac troponin and BNP, QTcF ≤470 msec
  • eGFR ≥70 mL/min/1.73 m²
  • Able to swallow capsules
  • Active disease subjects must have stable disease or better on recent treatment

Key Exclusion

  • BSA <0.25 m²
  • Currently receiving other investigational drugs or anticancer agents
  • Uncontrolled infection
  • DIPG subjects with progression or recurrence after initial radiation
  • Subjects unable to comply with safety monitoring requirements

NCT07224503

Phase II Randomized Controlled Trial of C-SMART Versus BE Well for Patients With Brain Tumors on Neurocognitive and Neuroimaging Outcomes

Organization/Sponsor: Virginia Commonwealth University


Example patient: A 52-year-old English-speaking patient with histologically confirmed glioma, three months post-surgery, experiencing memory deficits 2 SD below premorbid baseline, with stable internet access and no metal implants.

Phase 2

Interventions

  • Behavioral: BE Well
    Summary: BE Well is a cognitive intervention targeting brain tumor patients, focusing on cognitive strategies, mindfulness, and rehabilitation to improve cognitive function (Web Search).
  • Behavioral: C-SMART
    Summary: C-SMART combines cognitive strategies, mindfulness, and rehabilitation therapy delivered via telehealth to address cognitive deficits and improve quality of life in brain cancer patients (Web Search).

Key Inclusion

  • Confirmed primary brain tumor diagnosis by histology or imaging review
  • At least one neurocognitive domain >1.5 SD below average or premorbid functioning
  • >1 month post brain surgery and/or radiation therapy if applicable
  • Estimated premorbid intelligence >75
  • Age 18 or older
  • Primarily English speaking
  • Patient of Virginia Commonwealth University Neuro-Oncology clinic

Key Exclusion

  • Major neurocognitive impairment preventing intervention participation
  • Severe aphasia or inability to provide informed consent
  • Inability to attend weekly telehealth appointments
  • Clinically significant insomnia more interfering than cognitive symptoms
  • <1 month post brain surgery and/or radiation therapy
  • Metal in body (MRI contraindication)
  • Pregnant females of childbearing years
  • Unstable internet connection or inability to use teleconferencing software

NCT07076498

Phase 1 Trial of Engineered HSV-1 M032 in Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standard of Care Radiation Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 7-year-old child with newly diagnosed H3 K27M-mutant diffuse midline glioma in the pons, 6 weeks post-radiation, with a 2.5 cm surgically accessible tumor, Lansky score of 70, and normal organ function.

Phase 1

Interventions

  • Biological: M032
    Summary: M032 is a genetically engineered oncolytic HSV-1 with ICP34.5 deletion expressing IL-12, designed to selectively replicate in and lyse tumor cells while stimulating immune response via IL-12-mediated NK cell and CTL activation (NCI Thesaurus).

Key Inclusion

  • Age ≥ 36 months
  • Newly diagnosed diffuse midline glioma H3 K27M mutant or pontine DMG
  • Received standard radiation 4-8 weeks prior to enrollment
  • Tumor 1.0-4.0 cm diameter and surgically accessible
  • Karnofsky/Lansky score ≥ 60
  • Normal hematological, renal, and liver function
  • Adequate contraception for women of childbearing potential and men
  • Fully recovered from acute treatment-related toxicities

Key Exclusion

  • Previously received other investigational agents
  • Untreated symptomatic hydrocephalus
  • Primary spinal cord tumor
  • Pregnant or lactating females
  • On immunosuppressive therapy including corticosteroids at enrollment
  • Known HIV or immune deficiency
  • Active herpes infection with symptoms
  • Received live vaccine within 30 days prior to treatment

NCT06974370

Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and/or Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial) Genomic-based

Organization/Sponsor: University of Vermont Medical Center


Example patient: A 52-year-old woman with EGFR-mutant lung adenocarcinoma and two new 2 cm brain metastases, KPS 80, starting osimertinib without prior brain radiation.

Phase N/A

Interventions

  • Procedure: Active Surveillance
    Summary: Closely monitoring patient condition with regular exams and tests without treatment unless changes occur, avoiding radiation or surgery complications while detecting early disease progression (NCI Thesaurus).

Key Inclusion

  • Pathologically proven solid tumor malignancy within 5 years
  • At least 1 brain metastasis ≤3 cm not planned for radiation or surgery
  • Initiating systemic therapy expected to cause intracranial response
  • Brain penetrant targeted therapies, checkpoint inhibitors, HER2 antibody-drug conjugates, or anti-hormone therapies
  • Systemic therapy started or planned within 4 weeks of MRI showing new or progressive disease
  • Age ≥18 years
  • KPS >60
  • Ability to obtain contrast MRI with slice thickness ≤1.5 mm

Key Exclusion

  • Use of planned systemic therapy for brain metastases within last 6 months
  • Prior radiotherapy to active brain metastases
  • Pregnant or nursing
  • Known leptomeningeal disease
  • Serious medical comorbidities preventing participation

NCT06991101

Randomized Phase 2 Trial of Ruxolitinib in Combination With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma. Genomic-based

Organization/Sponsor: Baptist Health South Florida


Example patient: A 52-year-old patient with newly diagnosed IDH-wildtype glioblastoma, KPS 80%, adequate organ function, no prior brain tumor treatment, and MGMT methylation status confirmed by tissue testing.

Phase 2

Interventions

  • Radiation: Radiation Therapy
    Summary: Radiation therapy involves exposure of the target or whole body to radiation, often used as curative therapy or palliative treatment for cancer (NCI Thesaurus).
  • Drug: Temozolomide
    Summary: Temozolomide is an alkylating agent that converts to MTIC, methylating DNA at O6 and N7 positions of guanine to inhibit replication, indicated for newly diagnosed glioblastoma with radiotherapy and anaplastic astrocytoma (FDA label, NCI Thesaurus).
  • Drug: Ruxolitinib
    Summary: Ruxolitinib is a JAK1/JAK2 inhibitor that reduces inflammation and cellular proliferation by blocking JAK-STAT signaling pathways, indicated for myelofibrosis, polycythemia vera, and graft-versus-host disease (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically confirmed IDH-wildtype glioblastoma per WHO 2021 criteria
  • Age ≥18 years
  • Karnofsky performance status ≥70%
  • Adequate organ and bone marrow function (ANC ≥1500/mm3, platelets ≥100,000/mm3)
  • Sufficient tissue for MGMT and IDH testing
  • Negative pregnancy test for patients able to become pregnant
  • Disease-free ≥3 years if prior malignancy
  • MGMT methylated, unmethylated, or indeterminate status

Key Exclusion

  • Pregnant or breast-feeding patients
  • Concurrent therapy for brain tumor or investigational agents
  • Repeat craniotomy after radiation and temozolomide
  • Prior ruxolitinib use or allergy to study drug components
  • Warfarin use
  • Active hepatitis B or C requiring treatment
  • Significant cardiovascular disease or MI/thrombosis within 6 months
  • Concurrent malignancy except specific early-stage cancers

NCT05676489

MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors

Organization/Sponsor: University of Alabama at Birmingham


Example patient: A 52-year-old woman with recurrent grade IV glioblastoma previously treated with radiation, presenting with a 1.5-cm enhancing lesion on MRI, ECOG score 1, and normal renal function.

Phase N/A

Interventions

  • Diagnostic: [F-18]MeFAMP PET
    Summary: A radioconjugate of non-natural amino acid MeFAMP labeled with fluorine F-18 for PET imaging. Selectively taken up by tumor cells via amino acid transport system due to increased protein synthesis, accumulates without incorporation into proteins, enabling visualization of rapidly proliferating tumor cells. Source: NCI Thesaurus.

Key Inclusion

  • 18 years of age or older
  • Life expectancy greater than 12 weeks
  • Grade III or IV glioma previously treated with radiation (HGG cohort)
  • Enhancing lesion at least 1-cm suspicious for recurrent glioma (HGG cohort)
  • Brain metastasis from melanoma, lung, or breast cancer at least 1-cm (Metastasis cohort)
  • Plan for stereotactic radiation within 2 weeks (Metastasis cohort)
  • ECOG performance score of 2 or better (HGG and Metastasis cohorts)
  • Negative pregnancy test for females with childbearing potential

Key Exclusion

  • Use of investigational drug within 3 months
  • Pregnancy or breast feeding
  • Inability to complete PET scans
  • Significant renal or hepatic dysfunction (GFR <60 mL/min)
  • Conditions interfering with study participation

NCT07195591

Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM) Genomic-based

Organization/Sponsor: GT Medical Technologies, Inc.


Example patient: A 52-year-old patient with newly diagnosed IDH wild-type glioblastoma on MRI, KPS 80, medically fit for resection and standard chemoradiation without contraindications to temozolomide or gadolinium.

Phase N/A

Interventions

  • Drug: Temozolomide
    Summary: An alkylating agent that converts to MTIC at physiologic pH, methylating DNA at O6 and N7 guanine positions to inhibit replication. Indicated for newly diagnosed glioblastoma with radiotherapy and as maintenance, and for anaplastic astrocytoma. Penetrates CNS well. Source: FDA label, NCI Thesaurus.
  • Radiation: External Beam Radiation Therapy
    Summary: Radiation therapy delivering high-energy beams to the tumor from outside the body. Source: NCI Thesaurus.
  • Device: GammaTile®
    Summary: A proprietary Cs-131 radioactive source embedded in a permanently implanted resorbable collagen tile carrier, providing localized radiation treatment after brain tumor resection. Source: NCI Thesaurus.

Key Inclusion

  • Age ≥18 years
  • Radiographic suspicion of newly diagnosed glioblastoma
  • Medically and surgically appropriate for resection
  • Karnofsky Performance Scale score ≥70
  • Able to receive standard of care treatment

Key Exclusion

  • Previous biopsy diagnosis other than IDH wild-type GBM
  • Contraindications to temozolomide
  • Contraindications to MRI or gadolinium
  • Contraindications to non-contrast CT
  • Multi-focal enhancing tumors not encompassable in one operative field

NCT07053033

Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 62-year-old woman with lung cancer and a 12 mm brain metastasis showing progression 6 months after initial stereotactic radiosurgery, Karnofsky score 70, with biopsy-confirmed active tumor.

Phase N/A

Interventions

  • Procedure: LITT
    Summary: Laser Interstitial Thermal Therapy uses prolonged moderate temperature elevations to heat neoplasms, resulting in coagulative necrosis of heated tissue (NCI Thesaurus).
  • Procedure: Surgery
    Summary: Operative procedures to treat disease or injury (NCI Thesaurus).

Key Inclusion

  • Age ≥18 years
  • Karnofsky performance status ≥60
  • Radiographic progression of solid tumor brain metastasis after prior stereotactic radiosurgery ≥3 months prior
  • Measurable disease ≥5 mm on MRI
  • Active tumor on pathology from surgery/LITT
  • Acceptable candidate for repeat stereotactic radiosurgery
  • No leptomeningeal disease on imaging

Key Exclusion

  • Brain metastases from hematologic malignancies
  • Psychiatric illness or social situations limiting compliance
  • Pregnancy

NCT07050836

Contrast Enhanced Ultrasound in Neurosurgery to Improve Glioma Visualization and Border Demarcation

Organization/Sponsor: University of Colorado, Denver


Example patient: A 52-year-old male with recurrent glioblastoma, KPS 80, scheduled for second resection, no cardiac disease or infections, consents to contrast-enhanced intraoperative ultrasound.

Phase N/A

Interventions

  • Drug: Definity contrast during ultrasound
    Summary: Perflutren lipid microspheres are an intravenous ultrasound contrast agent that opacify chambers and improve border visualization via echogenic gas-filled microspheres activated by ultrasound (FDA label, NCI Thesaurus).

Key Inclusion

  • Aged 18-95 years
  • Planned standard of care surgery for presumed primary or known recurrent glioma
  • WHO performance status ≤2 (KPS ≥70)
  • Able to sign consent and comply with study procedures
  • Negative pregnancy test within 14 days for patients of childbearing potential

Key Exclusion

  • High risk of surgical site infection (e.g., 2+ previous craniotomies within 3 months)
  • Hypersensitivity to perflutren lipid microsphere components
  • Known active or chronic infections
  • Significant cardiac disease, right-to-left shunts, severe pulmonary hypertension, or uncontrolled hypertension
  • Pregnant or breastfeeding
  • Known sickle cell disease
  • Serious medical or psychological condition interfering with treatment delivery

NCT07091396

Enhancing Functional Recovery With Home-based Transcranial Direct Current Stimulation (tDCS) in Patients With Stroke, Neurodegeneration and Brain Tumors

Organization/Sponsor: Mayo Clinic


Example patient: A 68-year-old male with Parkinson's disease experiencing cognitive impairment affecting daily communication, 8 months post-diagnosis with expected survival beyond 6 months and no epilepsy or metallic implants.

Phase N/A

Interventions

  • Device: Soterix® tDCS - Lab treatment
    Summary: Non-invasive neuromodulation technique using low-intensity electrical currents to stimulate brain regions and modulate neural activity for functional recovery (Source: Web Search).
  • Behavioral: Cognitive-linguistic therapy
    Summary: Combines cognitive strategies and mindfulness techniques to improve cognitive function and language impairments, targeting rehabilitation and mental well-being (Source: Web Search).
  • Device: Soterix® tDCS - Home treatment
    Summary: Home-based non-invasive brain stimulation delivering low-intensity electrical currents to specific brain regions to modulate neural activity for recovery (Source: Web Search).

Key Inclusion

  • At least 3 months after ischemic/hemorrhagic/anoxic stroke
  • 3 months after completion of cranial radiation or cranial surgery for intracranial tumors
  • Neurodegenerative conditions including primary progressive aphasia, corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease, Alzheimer's disease
  • Expected survival >6 months
  • Functional impairment in language and/or cognition affecting quality of life

Key Exclusion

  • Pregnancy
  • Contraindication to tDCS including metallic implanted objects
  • Medical instability or inability to cooperate during study
  • Individuals with epilepsy

NCT07044557

MeDex: No Perioperative Dexamethasone in Brain Metastases

Organization/Sponsor: University of Louisville


Example patient: A 62-year-old ambulatory patient with a new 3 cm brain lesion and a lung mass confirmed as non-small cell lung cancer on biopsy, with minimal midline shift, no prior steroid use, and normal kidney function scheduled for craniotomy.

Phase N/A

Interventions

  • Drug withholding: Withholding perioperative Dexamethasone
    Summary: Dexamethasone is a synthetic corticosteroid and glucocorticoid receptor agonist that suppresses immune and inflammatory responses, used for inflammatory conditions and malignancies; this trial withholds it perioperatively to assess outcomes in brain metastases resection (FDA label).

Key Inclusion

  • New brain tumor(s) on imaging
  • Visceral mass(es) suspicious or confirmed for neoplasm
  • Age ≥ 18 years
  • ECOG performance status ≤ 2
  • Midline shift on MRI ≤ 10 mm
  • Craniotomy planned to resect >75% of enhancing mass
  • No contraindications for craniotomy

Key Exclusion

  • BMs not eligible for resection >2 cm in any dimension
  • >4 BMs not eligible for resection ≤2 cm
  • Treatment with laser interstitial thermal therapy
  • High concern for primary CNS lymphoma
  • Diagnosis of small cell lung carcinoma
  • Any receipt of Dexamethasone
  • Steroid use in the past month
  • Stage 4 chronic kidney disease (GFR<30)