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

Towards endoscopic ultrasound and 11C-5-HTP PET screening for pancreatic neuroendocrine tumors in Multiple Endocrine Neoplasia type 1 and Von Hippel Lindau disease - VHLMEN2008

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32173

Enrollment

Registered

2008-12-15

Start date

2009-02-12

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas tumors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary endpoint 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.	—

Measure

Time frame

Primary endpoint 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.

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Countries

Netherlands

Outcome results