Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease

Von Hippel Lindau disease (VHLD) is an inherited syndrome characterized by vascular malformations, kidney cancer, adrenal gland and pancreas tumors. The VHL protein is not functional in the different disease associated lesions which results in production of high amounts of vascular endothelial growth factor (VEGF). Currently there are no clinical, radiographic or molecular markers that can predict the natural history of a given lesion. With 89Zr-bevacizumab positron emission tomography (PET) scanning, VEGF can be visualized and quantified.

The investigators hypothesize that 89Zr-bevacizumab PET imaging is a useful tool to predict the behaviour of disease associated lesions in patients with VHLD.

Adult patients with VHLD who have had routine magnetic resonance imaging (MRI) scans of central nervous system (CNS) and abdomen will undergo a 89Zr-bevacizumab PET scan. MRI will be repeated within 12 months.

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Key information

Conditions

Von Hippel-Lindau Disease Abnormalities, Multiple Adenocarcinoma Adenoma Adenoma, Islet Cell Angiomatosis Carcinoma Carcinoma, Renal Cell Cardiovascular Diseases Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hemangioblastoma Hemangioma Hemangioma, Capillary Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Neurocutaneous Syndromes Neuroectodermal Tumors Neuroendocrine Tumors Pancreatic Diseases Pancreatic Neoplasms Pancreatic Neuroendocrine Tumor Paraganglioma Pheochromocytoma Renal Cell Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

clinically or genetically proven VHLD
at least 1 measurable, VHL associated lesion in the CNS
routine MRI of the CNS ≤ 6 weeks before inclusion
routine CT or MRI of upper abdomen ≤ 3 months before inclusion or planned ≤ 3 months after 89Zr-bevacizumab PET scan
age ≥ 18 years
written informed consent must be given according to good clinical practice (GCP), and local regulations

Exclusion criteria

pregnancy
any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, those conditions should be discussed with the patient before registration in the trial

Treatment and study plan

89Zr bevacizumab PET scan

Other

Patients will be injected intravenously with 37 MBq, protein dose 5 mg 89Zr-bevacizumab at day 0. PET scans will be done at day 4.

Other names: VEGF imaging

Primary outcomes

Detection rate of VHL associated lesions with 89Zr-bevacizumab PET scans in patients with VHLD

Time frame: An 89Zr-bevacizumab PET scan will be performed within 6 weeks after routine MRI CNS investigation, MRI will be repeated within 12 months.

Secondary outcomes

Progressive lesions within 12 months, defined as new lesions or lesions that show an increase in size of at least 5% of the longest diameter on MRI, or lesions that become symptomatic

Time frame: The baseline MRI scan will be compared with a follow-up MRI scan within 12 months

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

VHL Alliance

Registry information

Official study title

Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease

Acronym: VHLimage

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Sep 3, 2009
Registry last updated: May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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