The OCEANS trial: fluorescence guided surgery with methylene blue for better visualization of small intestine neuroendocrine tumors: a feasibility study.
- Conditions
- Small intestine neuroendocrine tumors (SI-NET)
- Registration Number
- NL-OMON24327
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion criteria
- Patients with lesions on the Galium-68-dotatate PET/CT scan suspected for a Small intestine Neuro-endocrine tumor (SI-NET);
OR
- Patients with biopsy proven SI-NET;
AND
- 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), serotoninnoradrenalin reuptake inhibitors (SNRI’s), tricyclic antidepressants (TCA’s), bupropion, or buspiron.
- 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 thestudy objectives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The in-vivo tumor to background ratio (TBR) of the primary tumor.
- Secondary Outcome Measures
Name Time Method The TBR of (lymph node) metastases<br>The number of occult lesions found<br>The optimal dose of MB<br>The optimal time frame for the administration of MB<br>Determine confirmation of your signal with fluorescence microscopy