Small intestine neuroendocrine tumors (SI-NET)
Conditions
Interventions
Patients receive an intravenous injection of methylene blue (0.5 - 1.0 mg/kg) during surgery after which near-infrared fluorescence imaging will be performed.
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The in-vivo tumor to background ratio (TBR) of the primary tumor. | — |
Secondary
| Measure | Time frame |
|---|---|
| The TBR of (lymph node) metastases The number of occult lesions found The optimal dose of MB The optimal time frame for the administration of MB Determine confirmation of your signal with fluorescence microscopy | — |
Contacts
Public ContactHidde Galema
Erasmus MC
Outcome results
None listed