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

November 5, 2012 updated by: S.F. Oosting, University Medical Center Groningen

Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected from a tertiary referral center for Von Hippel-Lindau disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • VEGF imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
An 89Zr-bevacizumab PET scan will be performed within 6 weeks after routine MRI CNS investigation, MRI will be repeated within 12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
The baseline MRI scan will be compared with a follow-up MRI scan within 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

VHL Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (ESTIMATE)

September 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METc2009.119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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