The OCEANS trial: fluorescence guided surgery with methylene blue for better visualization of small intestine neuroendocrine tumors: a feasibility study. - The OCEANS trial

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 17 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•- Patients with lesions on the Galium-68-dotatate PET/CT scan suspected for a
•Small intestine Neuro-endocrine tumor (SI-NET);
•- Patients with biopsy proven SI-NET;
•- With the primary SI-NET in situ
•- >= 18 years of age;
•- Before patient registration, written informed consent must be given according
•to ICH/GCP, and national/local regulations.

•- Patients taking the following medication 30 days or less prior to surgery:
•selective serotonin reuptake inhibitors (SSRI*s), serotonin noradrenalin
•reuptake inhibitors (SNRI*s), tricyclic antidepressants (TCA*s), bupropion, or
•- Use of serotonergic party drugs (MDMA, ecstasy, GHB, cocaine) 30 days or less
•prior to surgery.
•- Patients diagnosed with Glucose-6-Phosphate Dehydrogenase (G6DP) deficiency;
•- Patients with a clinical significant history of allergic reaction to MB
•- Patients who are pregnant or breastfeeding, female from childbearing
•potential without adequate contraceptives.
•- Incapacitated subjects.
•- Any condition that the investigator, surgeon or anaesthesiologist considers
•to be potentially jeopardizing the patient*s well-being or the study
•objectives.

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