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

Renal Cell Carcinoma Clinical Trial

— VHLimage  

Official title:

Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970970
• Other study ID #: METc2009.119
• Status: Completed
• Phase: N/A
• First received: September 2, 2009
• Last updated: November 5, 2012
• Start date: September 2009
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Renal Cell
• Hemangioblastoma
• Neuroendocrine Tumors
• Pancreatic Neuroendocrine Tumor
• Pheochromocytoma
• Renal Cell Carcinoma
• Von Hippel-Lindau Disease

Intervention

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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	VHL Family Alliance

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of VHL associated lesions with 89Zr-bevacizumab PET scans in patients with VHLD		An 89Zr-bevacizumab PET scan will be performed within 6 weeks after routine MRI CNS investigation, MRI will be repeated within 12 months.	No
Secondary	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		The baseline MRI scan will be compared with a follow-up MRI scan within 12 months	No