pancreatic neuroendocrine tumors in patients with MEN1 en VHL.
Conditions
Interventions
1. 11C-5-HTP-PET scan
2. Endo Ultrasonography with fine needle aspirtation
3. Bloodsamples.
Sponsors
dr. T.P. Links
Eligibility
Inclusion criteria
Inclusion criteria: The study populations covers two different groups: 1. Group A: MEN1 or VHL patients with signs of a pancreatic tumor (biochemically and/or on conventional imaging) will undergo regular follow-up visits to control tumor localization. These patients are eligible for inclusion providing that the time period between the available conventional imaging data and the investigational imaging procedures does not exceed 4 months; 2. Group B: MEN1 or VHL patients without signs of a pancreatic tumor (biochemically and on conventional imaging) are regularly scheduled for routine follow-up. During this routine follow-up, these patients are eligible to participate in the trial. Also, the conventional and investigational imaging procedures will be performed within a period of 4 months. INCLUSION CRITERIA: 1. Group A: A. Genetically proven MEN 1 or VHL, or clinically proven MEN1 or VHL also in first grade family members: B. Signs of a pancreatic tumor biochemically and/or on conventional imaging; C. The time period between the available conventional imaging data, biochemical markers and the investigational imaging procedures does not exceed 4 months; D. Over 24 years of age; E. In case of recent surgery at least a 3 months interval between surgery and EUS and 11C-HTP PET scanning; F. Written informed consent. 2. Group B: A. Genetically proven MEN 1 or VHL, or clinically proven MEN1 or VHL also in first grade family members; B. No signs of a pancreatic tumor biochemically and/or on conventional imaging; C. The time period between the available conventional imaging data, biochemical markers and the investigational imaging procedures does not exceed 4 months; D. Over 24 years of age; E. In case of recent surgery at least a 3 months interval between surgery and EUS and 11C-HTP PET scanning; F. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with any signs of neurological or psychiatric disorders that will preclude him/her from expressing her/his own free will; 2. Pregnancy; 3. Patients not eligible for surgical intervention; 4. Patients with alcohol abusus; 5. Patients with chronic pancreatitis; 6. VHL type 2C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group A: The number of new (unknown) pancreatic NET lesions in MEN1 or VHL patients with proven pancreatic involvement (anatomical, with or without biochemical neuroendocrine activity) and in MEN1 or VHL patients with proven neuroendocrine activity (biochemical, without anatomical localization) detected by EUS ± FNA and 11C-HTP PET. Group B: The number of new (unknown) pancreatic NET lesions in patiens with MEN1 or VHL during routine follow-up detected by EUS ± FNA and 11C-HTP PET. | — |
Contacts
Public ContactT.P. Links
University Medical Center Groningen Div Endocrinology PO Box 30 001
Outcome results
None listed