Towards endoscopic ultrasound and 11C-5-HTP PET screening for pancreatic neuroendocrine tumors in Multiple Endocrine Neoplasia type 1 and Von Hippel Lindau disease

Completed

Conditions: Pancreas tumors
10052547

Registration Number: NL-OMON32173

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Group A (40 patients)
- Genetically proven MEN 1 or VHL, or clinically proven MEN1 or VHL also in first grade family members.
- Signs of a pancreatic tumor biochemically and/or on conventional imaging.
- The time period between the available conventional imaging data, biochemical markers and the investigational imaging procedures does not exceed 4 months.
- Over 24 years of age
- In case of recent surgery at least a 3 months interval between surgery and EUS and 11C-HTP PET scanning.
- Written informed consent;Group B (50 patients)
- Genetically proven MEN 1 or VHL, or clinically proven MEN1 or VHL also in first grade family members.
- No signs of a pancreatic tumor biochemically and/or on conventional imaging
- The time period between the available conventional imaging data, biochemical markers and the investigational imaging procedures does not exceed 4 months.
- Over 24 years of age.
- In case of recent surgery at least a 3 months interval between surgery and EUS and 11C-HTP PET scanning.
- Written informed consent.

Exclusion Criteria

- Excluded are patients with any signs of neurological or psychiatric disorders that will preclude him/her from expressing her/his own free will.
- Pregnancy.
- Patients not eligible for surgical intervention.
- Patients with alcohol abusus.
- Patients with chronic pancreatitis.
- VHL type 2C

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br>Group A)<br /><br>The number of new (unknown) pancreatic NET lesions in MEN1 or VHL patients with<br /><br>proven pancreatic involvement (anatomical, with or without biochemical<br /><br>neuroendocrine activity) and in MEN1 or VHL patients with proven neuroendocrine<br /><br>activity (biochemical, without anatomical localization) detected by EUS ± FNA<br /><br>and 11C-HTP PET.<br /><br><br /><br>Group B)<br /><br>The number of new (unknown) pancreatic NET lesions in patiens with MEN1 or VHL<br /><br>during routine follow-up detected by EUS ± FNA and 11C-HTP PET. </p><br>

Secondary Outcome Measures