The OCEANS II trial: Fluorescence guided surgery with indocyanine green for better visualization of small intestine neuroendocrine tumors: a feasibility study
- Conditions
- hormone producing tumorsNeuro-endocrine tumors1002911210017998
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 31
Inclusion Criteria
- Patients with lesions on the 68Ga-DOTATATE-PET-CT scan suspected for a SI-NET;
OR
- Patients with biopsy proven SI-NET;
AND
- With the primary SI-NET in situ;
- >= 18 years old;
- Obtained informed consent according to ICH/GCP, and national/local
regulations.
Exclusion Criteria
- Patients known with an allergy for iodine, intravenous contrast or shellfish;
- Patients with hyperthyroidism;
- Patients pregnant or breastfeeding;
- Patients with an ASA classification of 4 or higher;
- 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 objective of this study is to assess feasibility of intraoperative<br /><br>visualization of small intestine neuroendocrine tumors (SI-NET). Feasibility is<br /><br>defined as a Tumor-to-Background Ratio (TBR) of >= 1.5 in at least 60% of the<br /><br>patients. TBR will be assessed based on in vivo measurements on the primary<br /><br>SI-NET. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To asses the ex vivo TBR of the primary SI-NET<br /><br>- To assess the TBR of (lymph node) metastases;<br /><br>- To assess the number of extra (occult) lesions found and their fluorescence<br /><br>intensity;<br /><br>- To assess fluorescence signal on the pathology slides;<br /><br>- To assess the optimal dose of ICG to visualize the primary tumor.</p><br>