6 results
The primary objectives are to determine the diagnostic performance of gadofosveset-enhanced T1-weighted MR imaging for the discrimination between pN0 and pN+ patients for both primary staging and restaging after chemoradiotherapy and to determine…
To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults
The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect anacceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. Then the MRL could…
Primary:* Evaluate the safety and tolerability of ALKS 7119 following oral administration of multiple ascending doses of ALKS 7119 in healthy male and female adultsSecondary:* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119…
The aim of this pilot-study is to examine the accuracy of MRL compared to current nodal staging methods. We expect an acceptable accuracy of the MRL based on earlier studies with gadofosveset enhanced MRI in rectum cancer patients. A positive MRL…
PRIMARYTo demonstrate an effect of recAP on 28-day all-cause mortality.SECONDARY1. To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).2. To investigate the effect of recAP on use of organ support, i.e., mechanical…