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

NCT ID: NCT00970970

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-11-30

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.

Conditions

Von Hippel-Lindau Disease; Hemangioblastoma; Renal Cell Carcinoma; Pheochromocytoma; Pancreatic Neuroendocrine Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Von Hippel Lindau

Adult patients with Von Hippel-Lindau disease

89Zr bevacizumab PET scan

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

VEGF imaging

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VHL Alliance

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sjoukje Oosting, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

METc2009.119

Identifier Type: -

Identifier Source: org_study_id