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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment
Von Hippel-Lindau Disease; Hemangioblastoma; Renal Cell Carcinoma; Pheochromocytoma; Pancreatic Neuroendocrine Tumor	Other: 89Zr bevacizumab PET scan

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	22 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease
Study Start Date :	September 2009
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	November 2012

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Von Hippel Lindau; Adult patients with Von Hippel-Lindau disease	Other: 89Zr bevacizumab PET scan; 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 Name: VEGF imaging

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 ]

Biospecimen Retention:   Samples With DNA

Blood samples will be taken at day 1 and at the day of the MRI scan for analysis of VEGF pathway related biomarkers (such as plasma VEGF, PDGF, placental growth factor (PlGF), soluble VEGF receptors) and endothelial activation markers (such as Von Willebrand Factor (VWF), plasminogen activator inhibitor type 1 antigen (PAI-1), tissue-type plasminogen activator antigen (t-PA) and circulating endothelial cells (CECs)). DNA analysis for evaluation of polymorphisms in genes involved in angiogenesis is optional. In available biopsy or resection specimens, additional molecular staining of VEGF pathway related proteins will be performed (such as VEGF, VEGF receptors, HIF).

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients will be selected from a tertiary referral center for Von Hippel-Lindau disease.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

University Medical Center Groningen

VHL Family Alliance

Investigators

Principal Investigator:	Sjoukje Oosting, MD	University Medical Center Groningen

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	S.F. Oosting, prinicipal investigator, University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00970970 History of Changes
Other Study ID Numbers:	METc2009.119
First Posted:	September 3, 2009
Last Update Posted:	November 6, 2012
Last Verified:	November 2012

Keywords provided by S.F. Oosting, University Medical Centre Groningen:

Vascular endothelial growth factor; von Hippel Lindau disease; molecular imaging; biomarker

Additional relevant MeSH terms:

Von Hippel-Lindau Disease; Carcinoma, Renal Cell; Neuroendocrine Tumors; Pheochromocytoma; Adenoma, Islet Cell; Hemangioblastoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site	Kidney Diseases; Urologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Paraganglioma; Adenoma; Pancreatic Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neurocutaneous Syndromes; Nervous System Diseases