Neurosurgery Clinical Trials
The Stanford Department of Neurosurgery is at the forefront of clinical trials, offering potential therapies not offered anywhere else in the world. Our studies examine therapies for everything from brain trauma and spinal cord injury to pediatric brain tumors and stroke. The results of these studies and the discoveries in our labs translate into new, innovative, and minimally-invasive therapies for patients.
Brain Tumor
Newly Diagnosed Glioma
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) concomitant with Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant with Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58)
PI: Lawrence Recht, MD
Research Coordinator: Sahara Rout
Contact: ssrout@stanford.edu
ClinicalTrials.gov#: NCT06556563
A Phase I Study of Tumor Treating Fields with 5-Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma
PI: Scott Soltys, MD
Study Status: Active, Not recruiting
ClinicalTrials.gov#: NCT04474353
Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T Cells (GD2CART) for Diffuse Intrinsic Pontine Gliomas (DIPG) and Spinal Diffuse Midline Glioma (DMG)
PI: Michelle Monje, MD, PhD
Study Status: Recruiting
ClinicalTrials.gov#: NCT04196413
Recurrent High Grade Glioma
Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults with Recurrent Glioblastoma Multiforme (GBM)
PI: Reena Thomas, MD PhD
Study Status: Recruiting
ClinicalTrials.gov#: NCT05474378
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
PI: Seema Nagpal, MD
Study Status: Recruiting
ClinicalTrials.gov#: NCT03382977
A Phase Ib Clinical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters Following Neoadjuvant Anti-PD-1 (Nivolumab), or the Combination of Anti-PD-1 Plus Anti-CTLA-4 (Nivolumab Plus Ipilimumab) in Patients With Surgically Accessible Glioblastoma
PI: Michael Lim, MD
Study Status: Active, Not recruiting
ClinicalTrials.gov#: NCT04606316
Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms during Neurosurgical Procedures
PI: Gordon Li, MD
Study Status: Recruiting
ClinicalTrials.gov#: NCT03510208
A Randomized Surgical Window of Opportunity Study with Dose Escalation to Evaluate Whether Oral Fluoxetine Can Induce Cytotoxic Lysosomal Stress and Enhance Temozolomide Efficacy in Clinical Glioma (The FLIrT Trial)
PI: Seema Nagpal, MD
Study Status: Recruiting
ClinicalTrials.gov#: NCT05634707
A Phase I Study of Multiple Doses of Neural Stem Cell-Based Oncolytic Virotherapy (NSC-CRAd-S-pk7) Administered Intracerebrally to Patients with Recurrent High Grade Gliomas
PI: Melanie Hayden Gephart, MD
Study Status: Recruiting
ClinicalTrials.gov#: NCT05139056
Brain and Spine Metastases
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients with Spinal Metastases (ALL-STAR)
PI: Erqi Pollum, MD
Study Status: Recruiting
ClinicalTrials.gov#: NCT06173401
Primary CNS Lymphoma
An Open-Label Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Tirabrutinib in Patients with Primary Central Nervous System Lymphoma (PCNSL)
PI: Neel Gupta, MD
Study Status: Recruiting
ClinicalTrials.gov#: NCT04947319
Cerebrovascular Surgery
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) Protocol
PI: Gary Steinberg, MD
NCT02089217
Study Status: Closed
Research Coordinator: Guiping Qin
Contact: neurosurgeryresearch@stanford.edu
The Neuroscience Brain Bank: Collection of Neurosurgical Tissue for Research
PI: Gary Steinberg, MD
Study Status: Recruiting
Research Coordinator: Gabriella Morton
Contact: neurosurgeryresearch@stanford.edu
A prospective, Multicenter study to Evaluate the Performance and Safety of the CerebroFlo EVD Catheter: C-CERFLO-001
PI: Lawrence Shuer, MD
NCT05113381
Study Status: Recruiting
Research Coordinator: Guiping Qin
Contact: neurosurgeryresearch@stanford.edu
Endocrinology
A multi-national, multi-centre, prospective, single-arm, observational, non-interventional post-authorisation safety study to investigate long-term safety of Sogroya® (somapacitan) in adults with growth hormone deficiency (AGHD) under routine clinical practice (NN8640-4515)
PI: Julia Chang, MD
Study status: Active/ Recruiting
ClinicalTrials.gov#: 05718570
Research Coordinator: Banu Priya
Contact: bpriya@stanford.edu
National US Pituitary Adenoma Surveillance Registry
PI: Julia Chang, MD
Study status: Active/ Recruiting
Research Coordinator: Banu Priya
Contact: bpriya@stanford.edu
Functional Neurosurgery
BrainGate2: Feasibility Study of an Intracortical Neural System for Persons with Tetraplegia
PI: Jaimie Henderson, MD
NCT00912041
Study Status: Recruiting
Research Coordinator: Guiping Qin
Contact: neurosurgeryresearch@stanford.edu
Pediatric Neurosurgery
Childhood Brain Tumor Tissue Consortium (CBTTC) Collection protocol
PI: Laura Prolo, MD
Study Status: Recruiting
Research Coordinator: Gabriella Morton
Contact: neurosurgeryresearch@stanford.edu
Advancing Treatment for Pediatric Craniopharyngioma: Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy
PI: Laura Prolo, MD
Study Status: Recruiting
Research Coordinator: Gabriella Morton
Contact: neurosurgeryresearch@stanford.edu
HCRN Core Data Project: Characterizing Patient Populations in the Hydrocephalus Clinical Research Network (HCRN)
PI: Kelly Mahaney, MD
Study Status: Recruiting
Research Coordinator: Gabriella Morton
Contact: neurosurgeryresearch@stanford.edu
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
PI: Laura Prolo, MD
Study Status: Recruiting
Research Coordinator: Gabriella Morton
Contact: neurosurgeryresearch@stanford.edu
NCT04085887
Renal Carcinoma
Non-interventional post-authorization study of belzutifan in adult patients with von Hippel-Lindau disease-associated renal cell carcinoma, pancreatic neuroendocrine tumor and/or central nervous system hemangioblastoma
PI: David Park , MD
Study status: Active/ Recruiting
Research Coordinator: Banu Priya
Contact: bpriya@stanford.edu
Spine
M6-C Artificial Cervical Disc IDE Post-Approval Study
PI: Lawrence Shuer, MD
NCT04122248
Research Coordinator: Guiping Qin
Contact: neurosurgeryresearch@stanford.edu
COMPaSS (Clinical Outcome Measures in Personalized aprevo Spine Surgery) Registry
PI: Atman Desai, MD
Study status: Active/ Not enrolling
Research Coordinator: Banu Priya
Contact: bpriya@stanford.edu