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 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
ClinicalTrials.gov#: NCT04474353
A Phase II Study of BPM31510 with Vitamin K1 in Subjects with Newly Diagnosed Glioblastoma (GB)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04752813
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Only open to adult patients at Stanford
PI: Kate Therkelsen, MD
ClinicalTrials.gov#: NCT05580562
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
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
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
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
ClinicalTrials.gov#: NCT03510208
Brain and Spine Metastases
A Phase IIa Study Assessing QBS72S For Treating Brain Metastases of Breast Cancer
PI: Melanie Hayden Gephart, MD
ClinicalTrials.gov#: NCT05305365
A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients With Resectable Brain Metastases
PI: Scott Soltys, MD
ClinicalTrials.gov#: NCT05438212
A Randomized Phase III TriaL Comparing SingLe- Versus Multi-Fraction Spine STereotActic Radiosurgery for Patients with Spinal Metastases (ALL-STAR)
PI: Erqi Pollum, MD
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
ClinicalTrials.gov#: NCT04947319
Cerebrovascular Surgery
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of REC-994 in the Treatment of Symptomatic Cerebral Cavernous Malformation - REC-994-201
PI: Gary Steinberg, MD, PhD
Study Status: Recruiting
Contact: neurosurgeryresearch@stanford.edu
ClinicalTrials.gov #: NCT05085561
Study of PHIL® (Precipitating Hydrophobic Injectable Liquid) Embolic System in the Treatment of Intracranial Dural Arteriovenous Fistulas
PI: Huy Do, MD
NCT03467542
Study Status: Not yet recruiting
Research Coordinator: Hong Ye and Anthony Bet
Contact: neurosurgeryresearch@stanford.edu
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) Protocol
PI: Gary Steinberg, MD
NCT02089217
Study Status: Recruiting
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: Hong Ye
Contact: neurosurgeryresearch@stanford.edu
A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia (DCI), in adult subjects with aneurysmal subarachnoid hemorrhage (aSAH)
PI: Gary Steinberg, MD
NCT03585270
Study Status: Enrollment open soon
Research Coordinator: Hong Ye
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
Contact: neurosurgeryresearch@stanford.edu
Functional Neurosurgery
Stereotactic Laser Ablation for Temporal Lobe Epilepsy
PI: Vivek Buch
NCT02844465
Study Status: Enrolling
Research Coordinator: Bharati Sanjanwala
Contact: neurosurgeryresearch@stanford.edu
BrainGate2: Feasibility Study of an Intracortical Neural System for Persons with Tetraplegia
PI: Jaimie Henderson, MD
NCT00912041
Study Status: Enrolling
Research Coordinator: Hong Ye, Anthony Bet
Contact: neurosurgeryresearch@stanford.edu
BrainGate3: Feasibility Study of a Fully-Implantable, Wireless Intracortical Neural Interface System for Persons with Tetraplegia
PI: Jaimie Henderson, MD
Study Status: Not yet enrolling
Contact: neurosurgeryresearch@stanford.edu
BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuralgia
PI: Michael Lim, MD
NCT03941834
Study Status: Enrolling
Contact: Anthony Bet
ENCASE II Randomized, two-arm, multicenter study to Evaluate the safety and efficacy of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery
PI: Jaimie Henderson, MD
Study Status: Not yet enrolling
Banu Priya Rathinam Radha Rajasekaran
Pediatric Neurosurgery
Childhood Brain Tumor Tissue Consortium (CBTTC) Collection protocol
PI: Laura Prolo, MD
Study Status: Recruiting
Research Coordinator: Anthony Bet
Contact: abet0915@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: Anthony Bet
Contact: abet0915@stanford.edu
The Park-Reeves Syringomyelia Research Consortium
PI: Laura Prolo, MD
Study Status: Recruiting
Research Coordinator: Anthony Bet
Contact: abet0915@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: Hong Ye
Contact: hye2@stanford.edu
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
PI: Laura Prolo, MD
Study Status: Recruiting
Contact: neurosurgeryresearch@stanford.edu
NCT04085887
Peripheral Nerve Surgery
Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
PI: Thomas Wilson, MD
Study Status: Recruiting
Research Coordinator: Hong Ye/ Anthony Bet
Contact: hye2@stanford.edu or abet0915@stanford.edu
| Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain PI: Anand Veeravagu, MD Study Status: Recruiting Contact: neurosurgeryresearch@stanford.edu NCT03556137 |
Pituitary
A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
Status: Not yet recruiting
PI: Laurence Katznelson, MD
NCT04076462
Research Coordinator: Bharati Sanjanwala
Contact: bharatis@stanford.edu
A Phase 3, open-label, single-arm, multi-center trial to assess the long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly
Status: Recruiting
PI: Laurence Katznelson, MD
NCT04125836
Research Coordinator: Bharati Sanjanwala
Contact: bharatis@stanford.edu
Spine
Improving Spine Care with Real-Time Objective Patient Tracking with Apple Watch
PI: Corinna Clio Zygourakis
NCT04379921
Contact: Parastou Fatemi
M6-C Artificial Cervical Disc IDE Post-Approval Study
PI: Lawrence Shuer, MD
NCT04122248
Contact: Anthony Bet or Guiping Qin
Stroke
A Phase 1/Phase 2 Safety, Tolerability and Efficacy Study of Intracerebral Transplantation of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke (ISS) and Early Evaluation of Potentially Useful Efficacy Parameters
NCT04631406
PI: Gary Steinberg, MD, PhD
Study Status: Enrolling
Research Coordinator: Guiping Qin gqin68@stanford.edu
Recruitment & screening Contact: Kathy McDonald kmcdonal@stanford.edu