6 results
Primary objective:To determine target lesions tumour response.Secondary objectives:* To determine overall tumour response.* To determine the liver specific progression-free survival.* To determine non-liver specific progression-free survival.* To…
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Primary objective:To establish the safety and toxicity profile of 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:* To evaluate efficacy of 166Ho-RE in hepatocellular carcinoma without curative treatment options in a non-…
(1) Establishing normal values (cut-offs) for bipolar and unipolar voltage mapping during sinus rhythm and pacing. (2) Establish normal values for conduction velocity during sinus rhythm of the 4 chambers. (3) Establish normal values for activation…
Primary objectives:* To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study Secondary objectives:* To establish the safety and toxicity profile of adjuvant 166Ho-RE after…
Primary ObjectiveTo evaluate the safety and tolerability of dutogliptin in combination with filgrastim in subjects with STEMI compared with placebo Secondary ObjectivesTo assess preliminary efficacy of dutogliptin in combination with filgrastim in…