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

Sponsor:	University Medical Centre Groningen
Collaborator:	VHL Family Alliance
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00970970

Purpose

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 and abdomen will undergo a 89Zr-bevacizumab PET scan. MRI will be repeated after 6 months.

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

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary paraganglioma-pheochromocytoma nonsyndromic paraganglioma von Hippel-Lindau syndrome

MedlinePlus related topics: Cancer Nuclear Scans Pheochromocytoma Von Hippel-Lindau Disease

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:

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 investigation, MRI will be repeated after 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progressive lesions after 6 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 an MRI scan after 6 months ] [ Designated as safety issue: No ]

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).

Estimated Enrollment:	30
Study Start Date:	September 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 approximately 1 hour post injection (day 0), at day 2 and at day 4. Other Name: VEGF imaging

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 on MRI
routine MRI of the CNS and upper abdomen ≤ 4 weeks before inclusion
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970970

Contacts

Contact: Sjoukje Oosting, MD	+31 503612821	s.oosting@int.umcg.nl
Contact: Thera Links, MD PhD	+31 503613962	t.p.links@int.umcg.nl

Locations

Netherlands
University Medical Center Groningen	Recruiting
Groningen, Netherlands, 9700 RB
Contact: Sjoukje Oosting, MD +31 503612821 s.oosting@int.umcg.nl
Contact: Thera Links, MD PhD +31 503613962 t.p.links@int.umcg.nl
Principal Investigator: Sjoukje Oosting, MD

Sponsors and Collaborators

University Medical Centre Groningen

VHL Family Alliance

Investigators

Principal Investigator:

Sjoukje Oosting, MD

University Medical Centre Groningen

More Information

No publications provided

Responsible Party:	S.F. Oosting, University Medical Center Groningen
ClinicalTrials.gov Identifier:	NCT00970970 History of Changes
Other Study ID Numbers:	METc2009.119
Study First Received:	September 2, 2009
Last Updated:	September 3, 2009
Health Authority:	Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:

Vascular endothelial growth factor
von Hippel Lindau disease
molecular imaging
biomarker

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Von Hippel-Lindau Disease
Pheochromocytoma
Hemangioblastoma
Neuroendocrine Tumors
Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

Kidney Diseases
Urologic Diseases
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Vascular Diseases
Cardiovascular Diseases
Paraganglioma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Hemangioma, Capillary
Hemangioma
Neoplasms, Vascular Tissue
Adenoma

ClinicalTrials.gov processed this record on February 09, 2012