12 results
Prospective study: The potential use of intraoperative, ICG based, fluorescence imaging of LN's during CRC lymphadenectomy.
Feasibility study: The potential use of intraoperative, ICG based, fluorescence imaging of LN*s during CRC lymphadenectomy.
Detection of breast carcinoma with an ICG enhanced optical imaging device in breast cancer patients.
Ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard lumpectomy procedure and used safely by the surgeon while detection of ICG within the tumour takes place. Duration: 1,5 hour clinical…
The primary objective is to determine the incidence of HFS in first line treatment with S-1 compared to capecitabine in patients with metastatic colorectal cancer. Secondary objectives include a comparison of efficacy.
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
The primary objective of Part 1 is the primary objective of the entire study.Part 1The primary objective of Part 1 is:* To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in…
* To assess the long-term safety and tolerability of ZX008.
The primary objective is to achieve intraoperative detection of histologically or cytologically proven GIST and metastases with ICG and NIR fluorescence imaging. The primary end-point is the diagnostic value of ICG in detecting GIST with NIR…
In this non-inferiority study, we aim to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care 99mTc in the SLN procedure for breast cancer patients.
The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…
To evaluate the bilateral SLN detection rate of intraoperative ICG with NIR fluorescence imaging compared to the current standard of care of 99mTc (with preoperative SPECT/CT) and blue dye.
Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo as an adjunctive therapy for pediatric and adult subjects with CDD Secondary (Safety): To characterize the…