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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00970970
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : November 6, 2012
VHL Alliance
Information provided by (Responsible Party):
S.F. Oosting, University Medical Center Groningen

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

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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

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

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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00970970

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University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
VHL Alliance
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Principal Investigator: Sjoukje Oosting, MD University Medical Center Groningen

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Responsible Party: S.F. Oosting, prinicipal investigator, University Medical Center Groningen Identifier: NCT00970970     History of Changes
Other Study ID Numbers: METc2009.119
First Posted: September 3, 2009    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012
Keywords provided by S.F. Oosting, University Medical Center Groningen:
Vascular endothelial growth factor
von Hippel Lindau disease
molecular imaging
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neuroendocrine Tumors
Von Hippel-Lindau Disease
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neurocutaneous Syndromes
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Hemangioma, Capillary