Clinical trial NCT00970970: Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease
Official title: Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Von Hippel-Lindau Disease
Hemangioblastoma
Renal Cell Carcinoma
Pheochromocytoma
Pancreatic Neuroendocrine Tumor
Keywords: Vascular endothelial growth factor
von Hippel Lindau disease
molecular imaging
biomarker
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: VHL Alliance
First posted: 2009-09-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from a tertiary referral center for Von Hippel-Lindau disease.

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.


Eligibility 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

Primary outcomes:
measure: Detection rate of VHL associated lesions with 89Zr-bevacizumab PET scans in patients with VHLD
timeFrame: An 89Zr-bevacizumab PET scan will be performed within 6 weeks after routine MRI CNS investigation, MRI will be repeated within 12 months.
Secondary outcomes:
measure: 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
timeFrame: The baseline MRI scan will be compared with a follow-up MRI scan within 12 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Sjoukje Oosting, MD
role: PRINCIPAL_INVESTIGATOR
References: