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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00970970
Other study ID # METc2009.119
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2009
Est. completion date November 2012

Study information

Verified date May 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
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 All
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


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 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.
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
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