Clinical trials
Allina Health Research is responsible for conducting clinical studies and collaborating with the community’s premier research houses to advance the treatment of our patients. We are committed to the improvement of patient care through discovery.
Allina Health Research collaborates with various health organizations through a variety of clinical trials. With the help of these partnerships, Allina Health is able to create new avenues for treatment.
With over 600 research studies to date, our experienced researchers and collaborators take pride in bettering the medical community and enhancing population health in the communities we serve.
Current clinical studies
Clinical trials are available at Allina Health Cancer Institute Coon Rapids, Minneapolis, & St. Paul.
Breast Cancer
Gilead GS-US-586-6144: Phase 2, randomized, open-label study of magrolimab in combination with nab-paclitaxel and paclitaxel versus nab-paclitaxel or paclitaxel in previously untreated unresectable, locally advanced or mTNBC (Phase 2 Cohort 1), magrolimab in combination with sacituzumab govitecan in patients with unresectable, locally advanced or mTNBC who have received 1 prior line of treatment in the unresectable, locally advanced or metastatic setting (Safety Run-in Cohort 2) (PI Krie).
EMBER-4 J2J-MC-JZLH: Now open A randomized, open-label, phase 3 study of adjuvant imlunestrant vs standard adjuvant endocrine therapy in patients who have previously received 2 to 5 years of adjuvant endocrine therapy for ER+, HER2- early breast cancer with an increased risk of recurrence (PI Krie).
Head & Neck Cancer
GS-US-548-5916: Phase 2 study of magrolimab combination therapy in patients with 1) untreated unresectable locally advanced/mHNSCC or 2) locally advanced/mHNSCC with 1-2 prior lines of therapy (PI He).
Hematologic Cancer
AbbVie M22-716: Now open Phase 1, open-label study to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in B-cell malignancies (PI He).
Pfizer C4971006: Now open Phase 1b/2, open-label study of PF-07901801 in combination with glofitamab after a fixed, single dose of obinutuzumab in participants with relapsed/refractory diffuse large B-cell lymphoma not eligible for stem cell transplantation (PI He).
Lung Cancer
AZ Compel D5162C00042: Phase 3, randomized, double-blind, placebo-controlled study of platinum plus pemetrexed chemotherapy plus osimertinib/placebo in patients with EGFRm, locally advanced/mNSCLC who have progressed extracranially following 1st line osimertinib therapy (PI Fares).
AZ PAC8 D9075C00001: Phase 3, randomized, double-blind, placebo-controlled, multicenter, international study of durvalumab plus domvanalimab (AB154) in participants with locally advanced (stage 3), unresectable NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (PI Fares).
Urothelial Cancer
Asieris YHGT-NP-01: Phase 1/2 open-label multicenter study to evaluate the safety and efficacy of oral APL-1202 in combination with tislelizumab compared to tislelizumab alone as neoadjuvant therapy in patients with muscle invasive bladder cancer (PI Harder).
Other
Exact Sciences ASCEND2 THR-CS-001: Biospecimen collection to detect cancers earlier through elective plasma-based CancerSEEK testing in patients >50 years (PI He).
- Untreated bladder, liver, uterine, stomach, ovarian, HNSCC, thyroid, small intestine, cervical, vulva, or testis or;
- Suspected bladder, kidney/renal pelvis, testicular, or ovarian cancer or;
- Healthy subjects without cancer.
Freenome FRNM-006: Opening soon A diagnostic case-control study for the development of multiomics blood tests for cancer screening in a real-world setting (PI Gorse).
- Cases, individuals who have been diagnosed with cancer.
- Controls, individuals who do not have signs or symptoms of cancer, a known current cancer diagnosis, or history of a treatment for cancer in the 5 years preceding enrollment.
If you are interested in more information regarding the previous studies, please call the Allina Health Cancer Institute Research Bridge Line: 612-863-8716
Metropolitan Heart & Vascular Institute
Learn more about the Metropolitan Heart & Vascular Institute clinical trials.Allina Health Minneapolis Heart Institute
Study name: Multicenter Imaging in Lead Extraction Study (MILES)Study summary: The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction.
Contact: Katie Bisch, katie.bisch@allina.com, 651-241-2913651-241-2913
More information: https://clinicaltrials.gov/ct2/show/NCT03772704
Study name: Reducing Lung Congestion Symptoms in Advanced Heart Failure (RELIEVE-HF)
Study summary: The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional class III or ambulatory class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.
Contact: Katie Schwister, katie.schwister@allina.com, 651-241-2816651-241-2816
More information: https://clinicaltrials.gov/ct2/show/NCT03499236
Study name: The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia (SAVAL)
Study summary: Two phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).
Contact: Nikki Gernes, nicole.gernes@allina.com, 651-241-2216651-241-2216
More information: https://clinicaltrials.gov/ct2/show/NCT03551496
Study name: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients (SOLVE CRT)
Study summary: This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
Contact: Nikki Gernes, nicole.gernes@allina.com, 651-241-2216651-241-2216
More information: https://clinicaltrials.gov/ct2/show/NCT02922036
Study name: Narrow QRS HF Patients Assessed by ECG Belt
Study summary: The purpose of this study is to quantitate electrical dyssynchrony in heart failure (HF) patients with a narrow QRS complexes (≤ 130 ms) using the ECG Belt. This is a pilot study that is designed to provide data that can be used in designing and implementing a prospective study of cardiac resynchronization therapy (CRT) in narrow QRS patients selected and optimized using the ECG Belt.
Contact: Chris Brown, christopher.brown2@alllina.com, 651-241-2806651-241-2806
More information: https://clinicaltrials.gov/ct2/show/NCT03367104
Study name: ECG Belt vs. Echocardiographic Optimization of CRT
Study summary: Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.
Contact: Chris Brown, christopher.brown2@alllina.com, 651-241-2806651-241-2806
More information: https://clinicaltrials.gov/ct2/show/NCT03305692
No current clinical trials.
If you are interested in learning more about any Neuroscience Research trials, please contact the Neuroscience Research Team at NeuroscienceResearch@allina.com
Neuro-Oncology Research Trials:
GBM AGILE: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM).
Summary:
Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.
More Information: https://clinicaltrials.gov/ct2/show/NCT03970447
DB102-01: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1.
Summary:
This randomized, multi-center phase III study will evaluate enzastaurin in comparison to a placebo, when added to radiation therapy and TMZ treatment. Eligible Glioblastoma (GBM) participants will be randomly assigned to one of the following groups:
- Radiation therapy + TMZ + enzastaurin
- Radiation therapy + TMZ + placebo
More Information: https://clinicaltrials.gov/ct2/show/NCT03776071
STaRT Registry: A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms.
Summary:
This is a registry study aimed at evaluating real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of GammaTiles.
More Information: https://clinicaltrials.gov/ct2/show/NCT04427384
EF-32 (TRIDENT): A Pivotal, Randomized, Open-Label Study of OPTUNE® (TTFIELDS, 200KHZ) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma.
Summary:
This study is designed to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.
More Information: https://clinicaltrials.gov/ct2/show/NCT04471844
Neuro-interventional Radiology Research Trials:
WEB-PAS: Post-Market Surveillance Study to Evaluate the Long Term Safety and Effectiveness of the WEB® Device.
Summary:
This is a Post-Market Surveillance study of the FDA-approved WEB Device. The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.
More Information: https://clinicaltrials.gov/ct2/show/NCT04839705
THUNDER: Acute Ischemic Stroke Study with the Penumbra System® including Thunderbolt™ Aspiration Tubing.
Summary:
The objective of this study is to demonstrate the safety and efficacy of the Penumbra System including Thunderbolt Aspiration Tubing (Thunderbolt) in a population presenting with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO) who are eligible for mechanical thrombectomy.
More Information: https://clinicaltrials.gov/ct2/show/NCT05437055
PRECISE: Perfusion imaging to identify posterior circulation candidates for thrombectomy
Summary:
Strokes are often caused by a blood clot inside a blood vessel that blocks the normal blood flow to a part of the brain; this type of stroke is called an ischemic stroke. The blockage can result in permanent brain damage. We are looking to enroll participants with an ischemic stroke due to a blockage of one of the vessels that supplies blood to the back of the brain. The purpose is to find out if advanced brain imaging can help identify which participants are most likely to benefit from a procedure to remove the blood clot to restore the blood flow to the brain.
Stroke Research Trials:
ARCADIA: AtRial Cardiopathy and Antithrobotic Drugs In prevention After cryptogenic stroke.
Summary:
ARCADIA is a phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at up to 200 sites in and out of the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 years on this trial.
More information: https://clinicaltrials.gov/ct2/show/NCT03192215
ASPIRE: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery. [PI: Dr. Mark Young, Lead Coordinator: Kaitlin Lundell]
Summary:
ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of apixaban (Eliquis®), compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF . Patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months.
More information: https://clinicaltrials.gov/ct2/show/NCT03907046
If you are interested in participating in any Courage Kenny Research Studies, please contact CKResearch@allina.com
Current Studies List:
Clinical implementation of wearable sensors to measure dual-task motor function in individuals with mild traumatic brain injury. [Principal Investigator: Margaret Weightman, PT, PhD]
The utility of sensor-based dual-task assessments has been established, but has not yet been translated into standard clinical practice. This study seeks to determine whether a Physical Therapist can reasonably conduct these sensor-based assessments in traditional PT clinical sessions.
Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion (PSC). [Principal Investigator: Mary Radomski, PhD, OTR/L]
A team composed of researchers from Courage Kenny Rehabilitation Institute (CKRI) propose to recruit a sample of individuals experiencing persistent symptoms after concussion to evaluate the efficacy of administering the Compass Course to a novel population, to improve psychological well-being, engagement in everyday activities, and purpose in life.
MENTOR - A MNSCIMS Project. [Principal Investigator: Dr. Amanda DeRasmi, DO]
As part of the MNSCIMS consortium, Courage Kenny Research is operating the MENTOR project, which seeks to validate a clinical tool to describe bowel dysfunction in the inpatient rehabilitation setting and facilitate management across the first-year post-injury.
Minnesota Regional Spinal Cord Injury Model System of Care. [Principal Investigator: Mary Radomski, PhD, OTR/L]
Courage Kenny Rehabilitation Institute has recently been designated as part of the Minnesota Regional Spinal Cord Injury Model Systems. This is one of 14 U.S. spinal cord model systems of care that received 5-year research funding from the U.S. Department of Health and Human Services National Institute on Disability, Independent Living, and Rehabilitation Research.
Purpose in Life Survey. [Principal Investigator: Mary Radomski, PhD, OTR/L]
Courage Kenny Research is investigating the Purpose in Life status in three different clinical populations, to see if novel cohorts can be investigated in future Purpose-driven interventions. Recruitment is currently occurring by invitation only.
Reading after Traumatic Brain Injury: Preliminary Development of a Guiding Model for Assessment and Treatment. [Principal Investigator: Katy O'Brien, PhD CCC-SLP]
Adults with traumatic brain injury are being invited to participate in a study which looks at the reading experiences of patients with TBI. In particular, this project looks to describe the reading experiences of adults with TBI, including habits, barriers, and facilitators. Additionally, this study is looking to validate a reading self-efficacy measure -- SOURSES-A.
Safe and Effective Shoulder Exercise Training in Manual Wheelchair User’s with SCI. [Principal Investigator: Margaret Weightman, PT, PhD]
This pilot study looks at the utility of a biomechanically-focused exercise intervention for manual wheelchair users with spinal cord injury. Participants will be randomized to one of two 12-week interventions, to determine whether a biomechanically-focused intervention will demonstrate improved short- and long-term outcomes.
SENSE - Feasibility of using continuous, remote symptom monitoring to identify and respond to early fall-risk for patients with chemotherapy-induced peripheral neuropathy. [Principal Investigator: Laura Gilchrist, PT, PhD]
This study is looking at using remote symptom monitoring to determine the relationship between chemotherapy-induced peripheral neuropathy and fall risk. Participants treated at Allina Health will use a mobile ecological momentary assessment (mEMA) to provide real-time feedback on symptom status.
Validity and Reliability of the Courage-Kenny Fibrosis Grading Scale for Post- Cancer Treatment Effects in Survivors of Breast and Head and Neck Cancer. [Principal Investigator: Margaret Weightman, PT, PhD]
The goal of this project is to refine and test the validity and feasibility of the Courage Kenny Fibrosis Grading Scale (CK-FGS), a test purported to quantify the degree of cancer-related tissue fibrosis experienced by those who have undergone surgery and radiation for various cancers.
No current clinical trials.
Study summary: The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products
Contact: Ned Tervola, ned.tervola@allina.com, 952-914-8594952-914-8594; Katie Sjostrom, katie.sjostrom@allina.com
More information: https://clinicaltrials.gov/ct2/show/NCT02047955