10 results
To assess safety, tolerability and pharmacokinetics of a single subcutaneous administration of HPV-NIRD1.
Prospective 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…
Feasibility study: The potential use of intraoperative, ICG based, fluorescence imaging of LN*s during CRC lymphadenectomy.
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…
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
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.
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.
Primary:To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG).Secondary:• To evaluate the impact of efgartigimod PH20 SC on disease severity• To evaluate the effect of…
Primary objective:- To assess the long-term safety and tolerability of efgartigimod PH20 SC (efgartigimod co formulated with recombinant human hyaluronidase PH20 [rHuPH20] for subcutaneous [SC] administration).Secondary objectives:- To determine the…