Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00970970
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : November 6, 2012
Sponsor:
Collaborator:
VHL Alliance
Information provided by (Responsible Party):
S.F. Oosting, University Medical Center Groningen

Tracking Information
First Submitted Date September 2, 2009
First Posted Date September 3, 2009
Last Update Posted Date November 6, 2012
Study Start Date September 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2012)
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. ]
Original Primary Outcome Measures
 (submitted: September 2, 2009)
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 investigation, MRI will be repeated after 6 months ]
Change History Complete list of historical versions of study NCT00970970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 9, 2012)
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 ]
Original Secondary Outcome Measures
 (submitted: September 2, 2009)
Progressive lesions after 6 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 an MRI scan after 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease
Official Title Visualizing VEGF Producing Lesions in 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples will be taken at day 1 and at the day of the MRI scan for analysis of VEGF pathway related biomarkers (such as plasma VEGF, PDGF, placental growth factor (PlGF), soluble VEGF receptors) and endothelial activation markers (such as Von Willebrand Factor (VWF), plasminogen activator inhibitor type 1 antigen (PAI-1), tissue-type plasminogen activator antigen (t-PA) and circulating endothelial cells (CECs)). DNA analysis for evaluation of polymorphisms in genes involved in angiogenesis is optional. In available biopsy or resection specimens, additional molecular staining of VEGF pathway related proteins will be performed (such as VEGF, VEGF receptors, HIF).
Sampling Method Non-Probability Sample
Study Population Patients will be selected from a tertiary referral center for Von Hippel-Lindau disease.
Condition
  • Von Hippel-Lindau Disease
  • Hemangioblastoma
  • Renal Cell Carcinoma
  • Pheochromocytoma
  • Pancreatic Neuroendocrine Tumor
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.
Other Name: VEGF imaging
Study Groups/Cohorts Von Hippel Lindau
Adult patients with Von Hippel-Lindau disease
Intervention: Other: 89Zr bevacizumab PET scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 5, 2012)
22
Original Estimated Enrollment
 (submitted: September 2, 2009)
30
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00970970
Other Study ID Numbers METc2009.119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party S.F. Oosting, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators VHL Alliance
Investigators
Principal Investigator: Sjoukje Oosting, MD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date November 2012