Improving Treatment Options for Somatostatin Type 2 Receptor Negative Neuroendocrine Tumor Patients
- Conditions
- metastasized neuroendocrine tumors (NETs)
- Registration Number
- NL-OMON23147
- Lead Sponsor
- Erasmus MC, Rotterdam, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
• Age =18 years
• Inoperable or metastasized neuroendocrine tumor with well-differentiated histology
(grade 1 or 2)
• SSTR2 negativity on 68Ga DOTATATE PET scan, defined as tumor uptake on 68Ga-
DOTATATE PET CT below that of the liver
• Hypotension, defined as systolic blood pressure <90mmHg
• Heart failure, defined as NYHA III-IV
• Impaired kidney function, defined as creatinine clearance <50ml/min
• Impaired liver function, defined as bilirubin or liver transaminases >3 times upper
normal range
• Uncontrolled hormonal symptoms including severe diarrhea, defined as >5 loose
stools / day
• Severe hypoalbuminemia, defined as serum albumin concentration <25g/L
• Epilepsy
• Known allergies / intolerances to valproic acid or hydralazine
• Existing drug treatment which cannot be stopped and interacts or interferes with
study drugs
• Inability to provide informed consent
• End of life care
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the percentage of patients that will have an uptake of<br>68Ga-DOTATATE in the tumor equal to or above that of the liver after the 14 days<br>treatment period.
- Secondary Outcome Measures
Name Time Method • Safety, as number of adverse events<br>• Drug levels of valproic acid<br>• Dosimetric evaluation of intra- and intertumoral SSTR2 expression<br>• Leucocyte methylation analysis