Clinical Pilot Program Awardees


Round Two 2023 Awardees

Title: Pilot Tranexamic Atomized for Pediatric Tonsillectomy Hemorrhage (pTEAPOT)

Synopsis: Tonsillectomy is one of the most common childhood surgical procedures performed in the United States. Despite improvement in surgical technique, four to five percent of children return to emergency departments (ED) for post-tonsillectomy hemorrhage (PTH), often resulting in hospital readmissions, blood transfusions, and/or surgical interventions. Tranexamic acid (TXA) ,an antifibrinolytic drug, has mitigated aerodigestive bleeding using nebulization in adult clinical trials. Our objective is to evaluate the feasibility to enroll children with PTH in the emergency room to receive nebulized TXA. Our secondary objective is to evaluate systemic absorption  of nebulized TXA. Within the pediatric emergency department, children aged 2 to 17 years old with a PTH will be approached to take part in the trial. After acceptance of consent, children will receive three doses of nebulized TXA.

Title: Title: Novel T2DM Management in Kidney Transplant: Transplant – PROTECT

Synopsis: Diabetic Kidney Disease is the most common cause of End-Stage Kidney Disease and is a global health emergency. Among kidney transplant (KTX) recipients (KTRs), 40% have diabetes. Anti-rejection therapies worsen diabetes, KTRs have increased CV mortality of up to >50%. To date, we do not know what the best early therapy is to treat post-transplant patients with T2DM.

  • This proposal aims to 1) shed new light on the unexplored area of SGLT2i and GLP1RA use on KTRs and their effect on renal, and CV protection, 2) elucidate novel mechanisms of action with these drugs including renal blood flow, microstructural integrity and effects on proinflammatory and early novel rejection biomarkers in KTRs with T2DM, 3) open the door to novel therapies for KTRs with T@DM to improve metabolic, renal, and CV health.

2023 Awardees

Title: Apobec3 expression in head and neck cancer as a novel biomarker of response to definitive chemoradiation: a pilot prospective cohort study

Synopsis: Locally advanced head and neck cancer, while curable with combined radiation and chemotherapy, has significant morbidity for survivors. Human papilloma virus (HPV) associated HNC is becoming more common and can potentially achieve favorable clinical outcomes with less intense therapy, although this is still being actively investigated. APOBEC3 (apolipoprotein B mRNA editing enzyme catalytic subunit-like protein 3), which has known connections with HPV, may help identify tumors with greater chemo- and radiation-sensitivity. This clinic trial will enroll patients with HPV associated HNC and identify whether APOBEC3 expression levels are related to clinical outcomes.

  • This clinical work will be supported by the lab of Dr Ruben Harris who is a leading expert on APOBEC and APOBEC expression in malignancy. Together, this work will inform the role of APOBEC3 in HNC, potentially help identify candidates for treatment de-escalation, and provide a foundation for exploring novel agents.

Title: Restriction Spectrum Imaging (RSI) MRI Technique for Evaluation of Response to Systemic Therapy in Bladder Cancer: Pilot Clinical Trial

Synopsis: Restriction Spectrum Imaging (RSI)-Magnetic Resonance Imaging (MRI) is a novel imaging technique that utilizes diffusion-weighted (DW) imaging to examine tissue microstructure. Patients with locally advanced bladder cancer are often treated with chemotherapy prior to surgery, but predicting which patients will respond to chemotherapy has been difficult. Several clinical trials have examined histologic and molecular features as predictors of response to chemotherapy, however, they remain of limited clinical utility. Non-responders to chemotherapy therapy experience significant side effects as well as potential delays in definitive therapy (surgery) with risks of disease progression. Predicting response to systemic therapy would support decision-making and patient selection by reserving systemic therapy for those who are most likely to benefit from it.

  • This clinical trial plans to enroll 100 patients with bladder cancer to determine if RSI-MRI can predict which patients will benefit from chemotherapy and thus better risk stratify patients and more precisely tailor therapy with the aim to improve outcomes while minimizing long term side effects from treatments. This clinical work will be supported by Robert Svatek, MD, MSCI, Professor and Chaif of Urology.
"This Program was initiated to support clinical trials at an early stage to help investigators collect preliminary data to secure extramural funding... Please join me in congratulating Drs. Dalwadi and Mansour on this well-deserved achievement. Their success reflects their commitment to excellence in research and clinical care." Robert Hromas, MD
Dean, Long School of Medicine