Clinical trials

This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET/CT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).

This observational study will examine how closely first-window indocyanine green (ICG) fluorescence corresponds to the extent of head and neck squamous cell carcinoma identified by tissue biopsy. ICG is a fluorescent dye given into a vein during surgery. Patients receive ICG as part of their clinical care, independently of whether they participate in this study. The study plans to enroll 25 adults undergoing surgery for confirmed or strongly suspected cancer. Researchers will record near-infrared images obtained during clinical ICG use, compare them with tissue pathology, and measure the strength, timing, and duration of fluorescence. The research analysis will not guide clinical or surgical decisions. Participants will be followed through 24 hours after surgery.

Polymyalgia rheumatica (PMR) is a condition that causes joint pain and stiffness, making it hard for people to do everyday tasks. Movement pattern training is a special, personalized rehabilitation program that aims to reduce pain by improving how people move during their daily activities. The investigators plan to test if it's possible to conduct a detailed study to find out how effective Movement pattern training is for people with PMR. The investigators will look at whether it helps them perform activities they want to do, reduce their use of certain medications, and strengthen their muscles. The investigators will also gather feedback from patients about their experience with Movement pattern training. This study will help us understand if carrying out a larger study on Movement pattern training's effectiveness is practical.

This is a prospective data collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young patients suspected of having ALL. Sixty patients will undergo collections of bone marrow and/or peripheral blood for the ChromoSeq® assay at time of initial workup as part of standard of care, and the patients will then be followed for clinical outcomes for up to 65 months.

The goal of this study is to evaluate the feasibility and preliminary efficacy of an artificial intelligence (AI)-generated personalized question prompt list (a list of suggested questions to ask during outpatient appointments) for patients with hematologic cancers. The intervention will involve tailoring a standardized prompt to patients' individual characteristics and concerns. This prompt will then be used to ask Washington University's (WashU) HIPAA compliant ChatGPT to generate personalized question lists for outpatient appointments. Analyses will assess the impact of personalized QPLs on patients' question-asking behavior; communicative self-efficacy; and self-reported amount and satisfaction with information obtained about their disease and its treatment. Sub-analyses will explore patterns in questions generated by WashU ChatGPT. Patients will also provide feedback pertaining to the perceived helpfulness and ease-of-use of WashU-ChatGPT-generated question lists, as well as their attitudes and intentions regarding use of AI chatbots and whether they would engage in pre-appointment AI-assisted question brainstorming independently in the future.

This study will demonstrate the impact of taVNS on reducing adverse events in NeuroICU patients, determine if taVNS reduces length of stay, and quantify the economic benefits of taVNS implementation in a broader neurocritical care population.

This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with hormone receptor (HR) positive, HER-2 negative metastatic or unresectable breast cancer receiving first-line or second-line treatment.

The aim of this study is to evaluate, in adults with HFrEF in Sri Lanka, the effects of an HFrEF polypill implementation strategy on the composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations, compared with usual care over a minimum of 12-months of follow-up. Primary outcome of the study: 1\) Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration Secondary outcomes of the study: 1. Rate of cardiovascular disease mortality over study duration 2. Rate of recurrent heart failure hospitalizations over the study duration 3. Rate of all-cause mortality over the study duration 4. Change in left ventricular ejection fraction at 12-months and end of study assessed by transthoracic echocardiogram 5. Change in BNP levels at 12 months and end of study 6. Change in overall and domain specific health-related quality of life at 12-months and end of study assessed by a translated validated version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) 7. Change in physician-reported New York Heart Association class at 12-months and end of study 8. Adherence to guideline-directed medical therapy assessed by pill count and MARS-5 questionnaire at baseline, 1-, 6-, 12-months, and end of study. Persistence assessed as continuation of assigned therapy at each follow-up visit. Dose optimization assessed as proportion achieving target doses (Strength 3 of the polypill, or comparable individual GDMT doses in the comparator arm) at 6-, 12-months, and end of study. Safety outcomes: 1. Proportion of participants with serious adverse events according to Good Clinical Practice guidelines over study duration 2. Proportion of participants with adverse events of special interest over study duration 3. Proportion of participants with adverse events leading to HF drug discontinuation over study duration 4. Mean change from baseline to 12-months and end of study in serum potassium (mEq/L) 5. Mean change from baseline to 12-months and end of study in serum creatinine (mg/dL) Participants will be randomly assigned 1:1 stratified by sex and site to one of two groups, intervention (experimental arm) or usual care (control arm). The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options. Both groups will be observed over a minimum of 12-months of follow-up to assess key outcomes.

This pilot, randomized control trial will test whether or not a specific circuit of position changes improves maternal outcomes in cases of prolonged labor. Patient who have prolonged labor will be approached for consent and randomization to one of two study groups: circuit intervention against routine standard of care position changes. 82 patients will be enrolled in the study. Exclusion criteria will include: any uterine infection prior to randomization, magnesium sulfate treatment, major fetal anomalies, BMI ≥50, non-reassuring fetal status prior to randomization, or any maternal diagnosis that precludes safety or feasibility of the circuit of maternal position changes. The 3 aims of the study will include: the outcome that the circuit of position changes has on the duration of the first stage of labor, maternal and neonatal morbidity, and maternal satisfaction.

The purpose of this study is to identify potential biomarkers that may predict the development of Alzheimer's disease in people who carry an Alzheimer's mutation.

The purpose of this study is to see if patients undergoing accelerated Intensive Cardiac Rehabilitation (ICR) (2 weeks after discharge) will improve exercise performance as well as on measures of quality of life after a cardiac hospitalization.

In Study 1, investigators will test the ability of each of the seven paradigms to differentiate between schizophrenia (SZ)/schizoaffective disorder (SZA) and matched healthy control subjects (HC) and to predict individual differences in clinical measures of hallucinations and delusions (as well as measures of function). Investigators will also directly compare the tasks in terms of predictive ability and psychometric properties and determine whether the tasks share variance or explain unique variance. This will include determining whether hallucinations and delusions are best explained by separate underlying processes or by a single process. Investigators will also test whether the model-based parameters from these studies are more precise and sensitive than standard behavioral methods for assessing deficits across psychotic disorders and for predicting hallucinations and delusions (Aim 1). Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. To generate a sample with sufficient variation in hallucinations and delusions, investigators will recruit the following groups that balance feasibility with clinical relevance: A) healthy controls (HC) \[HC, N=125\]; B) schizophrenia and schizoaffective disorder \[SZ/SZA, N=200\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups. Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. To generate a sample with sufficient variation in hallucinations and delusions, investigators will recruit the following groups that balance feasibility with clinical relevance: A) healthy controls (HC) \[HC, N=125\]; B) schizophrenia and schizoaffective disorder \[SZ/SZA, N=200\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups.

This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free tissue transfer in 20 eligible patients.

Diffuse large B-cell lymphoma is the most commonly occurring subtype of non-Hodgkin lymphoma, but treatment is often not curative, with as many as 50% of patients with adverse risk factors developing relapsed/refractory disease. CAR T-cell therapy has revolutionized modern cancer therapy, with axicabtagene ciloleucel and lisocabtagene maraleucel (anti-CD19 CAR T-cell therapies) FDA approved for second- or later-line treatment of relapsed/refractory large B-cell lymphoma. IL-7 plays a crucial role in T-cell homeostasis by inducing thymic differentiation, peripheral expansion, and extrathymic differentiation. It is the main regulator of T-cell hemostasis, inducing T-cell growth and proliferation in lymphopenic patients. There is data that suggests that exposure of T-cells to IL-7 may expand T-cells, prevent T-cell exhaustion, and improve effector functions. NT-I7 is a long-acting human IL-7 cytokine which has been shown in nonclinical studies to increase peripheral T-cells, antitumor efficacy, and tumor infiltrating lymphocytes, either as a monotherapy or in combination with chemo/radiotherapy and/or immune checkpoint inhibitors and CAR T therapy. This study is testing the hypothesis that the administration of NT-I7 following standard of care (SOC) approved CD19 CAR T-cell therapies for subjects with relapsed/refractory large B-cell lymphoma (LBCL) will be safe and tolerable and may increase the expansion and persistence of CAR T-cells in vivo, which may result in increased tumor response rate and improved clinical outcomes.

CareOrbit is a digital perioperative patient-education and care navigation platform developed by the St. Louis-based venture Total Orbit in collaboration with Washington University's CORTEX Business Incubator. For head and neck cancer (HNC) care, the platform is designed to address gaps in perioperative education by guiding patients through each stage of their surgical journey using structured modules, step-by-step instructional videos, and centralized educational resources. CareOrbit delivers physician-authored content tailored to an individual's surgical care, including overviews of surgical treatment, preoperative preparation, and expectations for postoperative recovery. Early anecdotal experiences suggest that patients appreciate the accessibility of the tool, but systematic evaluation is lacking in whether use of the tool improves understanding, satisfaction, and care outcomes. This project will address key knowledge gaps by employing a clinical trial to examine key clinical endpoints.

This is a multicenter, randomized, open-label, phase III study comparing standard of care use of somatostatin analogues (SSAs) to standard of care observation in patients with neuroendocrine neoplasms following treatment with Peptide Receptor Radionuclide Therapy (PRRT) (ethanol-stabilized Lu-177 dotatate).

This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).

This study is a single center, phase 1 clinical imaging study designed to assess the role of 68Ga-Galmydar Positron Emission Tomography (PET) imaging for detection of cardiotoxicity in human subjects with breast cancer or lymphoma undergoing treatment with anthracycline for cancer therapy.

The purpose of this study is to evaluate use of lovastatin, a drug that may lower CAV-1 levels, in order to increase HER2 expression on cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow advanced metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) is an FDA approved antibody drug conjugate for HER2-low and ultralow breast cancer and lovastatin is a cholesterol lowering agent.

This study pilots REACH, Resources and Education for Addressing Chronic Health, a service model to facilitate care coordination and communication across medical, school, and home settings. REACH seeks to address barriers to school-based asthma management, improving health and educational outcomes and reducing negative impacts for children with asthma.

This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.

AIMS 2 \& 3: In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.

Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers). The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.

The hypothesis for this study is that a preparative regimen that maximizes host immunosuppression without myeloablation will be well tolerated and sufficient for engraftment of donor hematopoietic cells. It is also to determine major toxicities from these conditioning regimens, within the first 100 days after transplantation.

This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).