In vivo REsponse evaluation of colorectal liver metastases during systemic therapy using optical SPECTroscopy techniques: a pilot study - RESPECT study

Philips Research0 个研究点目标入组 22 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•- Non-resectable colorectal liver metastases
•- Liver metastases of which a histological biopsy can safely be obtained:
•* Patients with safely accessible liver lesions according to an intervention-radiologist.
•* Patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgery.
•* Patients not using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID*s, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted.
•* Adequate hematology and coagulation status as measured by:
•* Hb > 6.0 mmol/L
•* Platelet count > 100 x 109/L
•* PT < 1.5 x Upper limit of normal (ULN)
•* APTT < 1.5 x ULN
•* PT-INR < 1.5 on the day of biopsy in patients using coumarines
•- Patients not known with contraindications for lidocaine (or its derivatives)
•- First line systemic treatment
•- Written informed consent, >18y

•- Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
•-Patients who have higher risk of bleeding, such as patients with coagulopathy or patients who receive anticoagulants

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