Improving Treatment Options for Somatostatin Type 2 Receptor Negative Neuroendocrine Tumor Patients

Recruiting

• Conditions: carcinoid; neuroendocrine tumor; 10029112; 10014713

• Registration Number: NL-OMON55794
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Age >=18 years
• Inoperable or metastasized neuroendocrine tumor with well-differentiated
histology (grade 1, 2 or 3)
• SSTR2 negativity or low uptake on 68Ga DOTATATE PET scan, defined as tumor
uptake on 68Ga-DOTATATE PET CT below that or equal to that (Krenning Score 1 or
2) of the liver

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• 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
• 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
<p>The primary endpoint will be the percentage of patients that after treatment<br /><br>will have an uptake of 68Ga-DOTATATE that is at least one point higher on the<br /><br>Krenning scale.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include safety monitoring, circulating drug levels,<br /><br>dosimetric evaluations and leucocyte methylation analysis.</p><br>