121 results
1. To compare the following imaging technologies to the current practice of histology of pelvic lymph node dissection: a. PSMAGa68 PET b. Nano MR Lymphography and an enhanced arterial map (Nano MRL / EAM) to locate the position of the lymph nodes2.…
To validate the use of 3 and 7 Tesla nano-MRI in restaging locally advanced rectal cancer by node-to-node matching of the results of nano-MRI with pathology as the gold standard.
Safety ObjectiveThe safety objective for this study is as follows:* To evaluate the safety and tolerability of atezolizumab in pediatric and young adult patients, focusing on the nature, frequency, and severity of serious and non-serious adverse…
To establish preliminary safety and tolerability of single- and multiple-ascending oral doses of MYK 491 in ambulatory patients with stable heart failure with reduced ejection fraction (HFrEF)
Primary objectives: To evaluate safety of ZED88082A in combination with CED88004S. To determine appropriate ZED88082A/CED88004S dosing and PET imaging time-points. To evaluate pharmacokinetics (PK) of ZED88082A/CED88004S in patients before and…
Primary* To compare TFFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with LOXO-292 versus cabozantinib or vandetanib.Secondary* To compare other efficacy outcomes, based on RECIST 1.1 criteria, observed in…
The first objective is to improve preoperative staging with 3T NANO-MRI regarding the detection of lymph node metastases in patients with a pancreatic or periampullary carcinoma when compared to a conventional contrast-enhanced CT or MRI. Other…
Three cohorts will be included consisting of subjects with biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and all other solid tumorhistologies not included in Cohorts 1-2 such as NSCLC, head and neck cancer, thyroid cancer, oral…
The primary objective of the study is to evaluate the efficacy of treatment with AG-348, as assessed by the reduction in transfusion burden.Secondary: The secondary objective of this study is to evaluate the safety of treatment with AG 348.
Primary:• To evaluate the efficacy of treatment with AG-348 compared with placebo in increasing hemoglobin (Hb) concentrationsSecondary:• To evaluate the safety of AG-348• To determine the effect of the study treatment regimens on markers of…
Part A - CX-2009 Monotherapy: Every 21-Day Dosing RegimenThe primary objective of Part A is to determine the safety profile of CX-2009, the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), and the dose-limiting toxicities(DLTs) of CX-…
Coprimary: The coprimary objectives of this study are to evaluate the efficacy of ontamalimab in subjects with moderate to severe Crohn*s disease (CD) in:* Inducing clinical remission based on 2 item patient reported outcome (PRO) (abdominal pain…
Primary: To evaluate the efficacy of ontamalimab as maintenance treatment of remission, based on composite score of patient reported symptoms and centrally read endoscopy, in subjects with moderate to severe ulcerative colitis (UC).Key Secondary:*…
PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…
The objectives of this extension trial are to assess the long-term safety and maintenance of efficacy beyond 2 to 2.5 years of treatment with glepaglutide in adult patients with SBS.Primary Objective:To evaluate the long-term safety of glepaglutide…
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…
Our primary objective is:i. To assess the quantity and regional distribution of [18F]DPA-714 binding as a marker of microglial activation in patients with FTD compared to controls. Our secondary objectives are: i. To compare the quantity and…
Coprimary: The coprimary objectives of the study are to evaluate the efficacy of ontamalimab as maintenance treatment in subjects with moderate to severe Crohn*s disease (CD) based on:* Clinical remission based on 2 item patient-reported outcome (…
Primary Objective* To evaluate the efficacy and safety of tofacitinib in subjects in stable remission on 10 mg BID who decrease the dose to and remain on 5 mg BID (*5 mg BID dose group*) compared to subjects remaining on 10 mg BID. Secondary…
The objective of the study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.