hormone producing tumors Neuro-endocrine tumors
Conditions
Interventions
Patients will be administered to the hospital a day prior to surgery and will
receive a single intravenous dose of ICG at least 18 hours prior to surgery
(1.0 mg/kg, 2.5 mg/kg or 4.5 mg/kg).
The abd
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess feasibility of intraoperative visualization of small intestine neuroendocrine tumors (SI-NET). Feasibility is defined as a Tumor-to-Background Ratio (TBR) of >= 1.5 in at least 60% of the patients. TBR will be assessed based on in vivo measurements on the primary SI-NET. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To asses the ex vivo TBR of the primary SI-NET - To assess the TBR of (lymph node) metastases; - To assess the number of extra (occult) lesions found and their fluorescence intensity; - To assess fluorescence signal on the pathology slides; - To assess the optimal dose of ICG to visualize the primary tumor. | — |
Countries
Netherlands
Outcome results
None listed