hormone producing tumors Neuro-endocrine tumors
Conditions
Interventions
After the laparotomy, 0.5 - 1.0 mg / kg MB will be administered. In the 10 - 15
minutes after that, images will be made of the tumor and possibly of the (lymph
node) metastases with a NIR camera.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
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), serotonin noradrenalin 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 the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the Tumor to Background ratio (TBR). This is determined on the primary tumor. A TBR> 2.0 is defined as 'feasible'. If this is the case in at least 60% of the tumors, the method is defined as a success. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the TBR of (lymph node) metastases Determine the number of occult lesions found Determine the optimal dose of MB Determine the optimal time frame for the administration of MB Determine confirmation of your signal with fluorescence microscopy | — |
Countries
Netherlands
Outcome results
None listed