Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease (VHLimage)
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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 (CNS) and abdomen will undergo a 89Zr-bevacizumab PET scan. MRI will be repeated within 12 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 |
- 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. ] [ Designated as safety issue: No ]
- 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 ] [ 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).
| Enrollment: | 22 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 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 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 |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00970970
| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9700 RB | |
| Principal Investigator: | Sjoukje Oosting, MD | University Medical Centre Groningen |
More Information
No publications provided
| Responsible Party: | S.F. Oosting, prinicipal investigator, University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT00970970 History of Changes |
| Other Study ID Numbers: | METc2009.119 |
| Study First Received: | September 2, 2009 |
| Last Updated: | November 5, 2012 |
| 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:
|
Von Hippel-Lindau Disease Adenoma, Islet Cell Apudoma Carcinoid Tumor Carcinoma, Renal Cell Neuroendocrine Tumors Adenocarcinoma Adenoma Angiomatosis Carcinoma Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases |
Kidney Diseases Kidney Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Neurocutaneous Syndromes Neuroectodermal Tumors Pancreatic Diseases Pancreatic Neoplasms Urogenital Neoplasms Urologic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015