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

Completed

Conditions: hormone producing tumors
Neuro-endocrine tumors
10029112
10017998

Registration Number: NL-OMON56617

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the Tumor to Background ratio (TBR). This is determined<br /><br>on the primary tumor. A TBR> 2.0 is defined as 'feasible'. If this is the case<br /><br>in at least 60% of the tumors, the method is defined as a success.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Determine the TBR of (lymph node) metastases<br /><br>Determine the number of occult lesions found<br /><br>Determine the optimal dose of MB<br /><br>Determine the optimal time frame for the administration of MB<br /><br>Determine confirmation of your signal with fluorescence microscopy</p><br>