Northwestern University Feinberg School of Medicine
Department of Neurological Surgery
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Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Learn more about our work via the Feinberg Office of Research Clinical Trials page, and find specific trials by searching for a disease or condition below.

For pediatric clinical trials, visit the Ann & Robert H. Lurie Children's Hospital of Chicago website.

For more information on neuro-oncology clinical trials, visit the Robert H. Lurie Comprehensive Cancer Center of Northwestern University website.

Chris Amidei, Director of Clinical Research 312-695-9124Please contact Chris Amidei, Director of Clinical Research at 312-695-9124 or christina.amidei@nm.org for more information on trials.

 
Trials

A Prospective, Multicenter Study of Artemis a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage (MIND)

This study addresses a type of bleeding in the brain called an intracerebral hemorrhage (ICH). This is a serious medical condition and the rate of death resulting from it is very high. Many of those who survive are disabled. The amount of brain injury seems to be related to the …
This study addresses a type of bleeding in the brain called an intracerebral hemorrhage (ICH). This is a serious medical condition and the rate of death resulting from it is very high. Many of those who survive are disabled. The amount of brain injury seems to be related to the size of the blood clot that forms in the head from the bleeding. The purpose of this study is to better understand how well and how safely the Artemis Neuro Evacuation Device (Artemis Device) impacts patients that have bleeding in their brain and compare that with patients who are not treated with the Artemis Device. The Artemis Device, used with the Penumbra Aspiration Pump, is designed to help remove blood and blood clots from the brain. This study will help to determine if more patients survive and have a better recovery after removing an ICH than if it wasn’t done.

The Artemis Device is a medical device that has been cleared by the United States Food and Drug Administration (FDA) for controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in combination with a Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration System. The device is commercially available in the United States.

Eligibility Criteria

Patients with bleeding in the brain causing a type of stroke (intracerebral hemorrhage or ICH) may be eligible for this study.

Principal InvestigatorJahromi, Babak SJahromi, Babak S
Location(s)
  • Map it 259 E. Erie St. Nineteenth Floor
    Chicago, IL
  • Map it 251 E. Huron St. Fifth Floor, Suite 704
    Chicago, IL
  • Map it 25 N. Winfield Road Suites 424 and 431
    Winfield, IL
  • Map it 25 N. Winfield Road
    Winfield, IL
ClinicalTrials.gov IdentifierNCT03342664IRB number STU00209486
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(xIRB) NCI CIRB: Alliance A071701: Genomically-Guided Treatment Trial in Brain Metastases

The purpose of this study is to test good and bad effects of different drugs against metastatic brain tumors with altered genes. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. Researchers have looked at the DNA material (genes) that can be affected in brain metastases and have found several genes that are altered, or mutated. There are medications that target these genes.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your metastatic cancer. The usual approach is defined as care most people get for your metastatic cancer.

Eligibility Criteria
  • Participantsmust be 18 years or older

  • Participants must have a confirmed diagnosis of cancermetastasized to the brain
Principal InvestigatorKumthekar, Priya UKumthekar, Priya U
Location(s)
  • Map it 201 E. Huron St.
    Chicago, IL
ClinicalTrials.gov IdentifierNCT03994796IRB number STU00211229
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Phase 1/2 trial of blood-brain barrier opening with the SonoCloud-9 implantable ultrasound device and treatment with albumin-bound paclitaxel in patients with recurrent glioblastoma

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be …

Eligible patients will undergo craniotomy for tumor resection. During the tumor resection and when possible, an initial low dose of albumin-bound paclitaxel will be given following sonication. In select patients, the sonication procedure may occur immediately after the test dose of chemotherapy is administered. The sonication device will be implanted at the end of the procedure. In phase 1, about two weeks after surgery, patients will undergo sonication and albumin-bound paclitaxel administration with MRI to quantify extent of blood brain barrier opening. Sonication and administration of albumin-bound paclitaxel will continue every 3 weeks until disease progression. The planned albumin-bound paclitaxel starting dose is 40 mg/m2, to be escalated in the absence of significant toxicity up to 260 mg/m2. Blood samples for circulating tumor DNA will also be collected before and after each sonication. In phase 2, pre-sonication carboplatin at AUC 5 will be added to the regimen, with a safety run-in for the first 6 patients.

Eligibility Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Isocitrate Dehydrogenase 1 (IDH1) wild-type glioblastoma on pathology from initial surgery (e.g. IDH R132H neg); morphologic or molecular determination of grade 4
  • Ability to undergo contrast-enhanced MRI
  • Radiographic evidence of tumor recurrence/progression after failure of 1 - 2 lines of prior therapy
  • Measurable or evaluable disease

  • Measurable: contrast-enhancement (bidirectional diameters ≥ 1cm) on MRI
  • Non-measurable/evaluable: contrast-enhancement diameters < 1 cm
  • Maximal tumor diameter pre-surgery ≤ 70 mm on T1wMRI
  • Candidate for at least partial surgical resection
  • Greater 12 weeks from completion of radiation therapy
  • Age ≥ 18 years
  • If receiving dexamethasone for mass effect, a stable daily dose of dexamethasone at < 6 mg within 7 days of registration, or if dexamethasone dose is decreasing, average daily dose of < 6 mg in the 7 days prior to registration. Patients on dexamethasone for reasons other than mass effect may still be enrolled.
  • WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) of ≥70)
  • Adequate hepatic, renal and bone marrow function, documented with normal laboratory values or no more than grade 1 outside the norm performed within 14 days prior to registration
  • For patients with a childbearing potential

  • Negative pregnancy test within 14 days prior to registration
  • Agreement to use adequate contraception for the duration of study participation, and for 3 and 6 months after the last dose of albumin-bound paclitaxel for men and women of childbearing potential, respectively.
  • Have the ability to understand and the willingness to sign a written informed consent prior to registration on study
  • Be willing and able to comply with the protocol for the duration of the study
  • Provide written, signed and dated informed consent prior to study registration. NOTE: no study-specific screening procedures may be performed until written consent has been obtained
  • Exclusion Criteria:

  • Have multifocal disease that cannot be encompassed in the ultrasound fields:

  • e.g. > 70-mm apart
  • tumor located in the posterior fossa
  • Patients at risk of cranial wound dehiscence
  • Have uncontrolled epilepsy or require treatment with enzyme-inducing antiepileptics
  • Have clinical evidence of peripheral neuropathy on examination
  • Have received any other investigational agents within 4 weeks of registration
  • Have received prior therapy with or have history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel or carboplatin
  • Medical contraindications to Abraxane® or carboplatin
  • Have an uncontrolled intercurrent illness
  • Are pregnant or nursing
  • Have a history of active malignancy within 3 years prior to registration.
  • Have a known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in Definity® (the FDA-approved ultrasound contrast agent to be used in this study)
  • Patients with coils, clips, shunts, intravascular stents, and/or non-removable wafer, non resorbable dura substitute, or reservoirs.
  • Patients with medical need to continue antiplatelet therapy.
  • Patients with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome (patient at risk for microbubble reaction).
  • Patients with impaired thermo-regulation or temperature sensation (due to device)
  • Principal InvestigatorSonabend Worthalter, Adam MendelSonabend Worthalter, Adam Mendel
    Location(s)
    • Map it 675 N. Saint Clair St. Twentieth Floor
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT04528680IRB number STU00212298
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    NRG BN012

    This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in …

    This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.

    Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial.

    Eligibility Criteria

    Some of the eligibility criteria include:

    · Radiographic confirmation of 1-4 brain metastases

    · Participants must be 18 or older

    · Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years cancer based on documented pathologic diagnosis within the past 3 years

    Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

    Principal InvestigatorMagill, Stephen T.Magill, Stephen T.
    Location(s)
    • Map it 201 E. Huron St.
      Chicago, IL
    • Map it 4405 Weaver Pkwy
      Warrenville, IL
    ClinicalTrials.gov IdentifierNCT05438212IRB number STU00218228
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    RESET-RA

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).…

    This study will evaluate the safety and effectiveness of the SetPoint Medical System (study device) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA), who have had an inadequate response or intolerance to biologic or targeted synthetic Disease Modifying Anti-Rheumatic Drugs (DMARDs).

    Eligibility Criteria

    Inclusion Criteria:

    • 22-75 years of age at screening
    • Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
    • Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
    • Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

    Exclusion Criteria:

    • Untreated or poorly controlled psychiatric illness or history of substance abuse
    • Significant immunodeficiency due to underlying illness
    • History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
    • Clinically significant cardiovascular disease
    • Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
    • Uncontrolled fibromyalgia
    • History of left or right carotid surgery
    • History of unilateral or bilateral vagotomy, partial or complete splenectomy
    • Recurrent vasovagal syncope episodes
    • Current, regular use of tobacco products
    Principal InvestigatorRuderman, Eric MRuderman, Eric M
    Location(s)
    • Map it 259 E. Erie St. Nineteenth Floor
      Chicago, IL
    • Map it 675 N. Saint Clair St. Fourteenth Floor, Suite 100
      Chicago, IL
    ClinicalTrials.gov IdentifierNCT04539964IRB number STU00213547
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    Evoked Compound Action Potentials for Parkinson’s Disease (eCAP-PD) Study: A prospective, multicenter, single-arm feasibility study examining ECAP-controlled, closed-loop spinal cord stimulation for Parkinson’s Disease

    The purpose of this study is to evaluate the safety and initial efficacy of ECAP-controlled closed-loop spinal cord stimulation (SCS) to treat patients with Parkinson’s Disease symptoms.…

    The purpose of this study is to evaluate the safety and initial efficacy of ECAP-controlled closed-loop spinal cord stimulation (SCS) to treat patients with Parkinson’s Disease symptoms.

    Eligibility Criteria

    Subject must have moderate/severe freezing of gait and/or tremor considered as a significant source of impairment in the management of their Parkinson's disease.

    Principal InvestigatorVerhagen Metman, LeonardVerhagen Metman, Leonard
    ClinicalTrials.gov IdentifierNCT02924129IRB number STU00220312
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