Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease (VHLimage)
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| ClinicalTrials.gov Identifier: NCT00970970 |
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Recruitment Status :
Completed
First Posted : September 3, 2009
Last Update Posted : November 6, 2012
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Von Hippel-Lindau Disease Hemangioblastoma Renal Cell Carcinoma Pheochromocytoma Pancreatic Neuroendocrine Tumor | Other: 89Zr bevacizumab PET scan |
| Study Type : | Observational |
| Actual Enrollment : | 22 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | November 2012 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Von Hippel Lindau
Adult patients with Von Hippel-Lindau disease
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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 |
- 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. ]
- 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 ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970970
| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9700 RB | |
| Principal Investigator: | Sjoukje Oosting, MD | University Medical Center Groningen |
| Responsible Party: | S.F. Oosting, prinicipal investigator, University Medical Center Groningen |
| ClinicalTrials.gov Identifier: | NCT00970970 History of Changes |
| Other Study ID Numbers: |
METc2009.119 |
| First Posted: | September 3, 2009 Key Record Dates |
| Last Update Posted: | November 6, 2012 |
| Last Verified: | November 2012 |
Keywords provided by S.F. Oosting, University Medical Center Groningen:
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Vascular endothelial growth factor von Hippel Lindau disease molecular imaging biomarker |
Additional relevant MeSH terms:
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Von Hippel-Lindau Disease Carcinoma, Renal Cell Neuroendocrine Tumors Pheochromocytoma Adenoma, Islet Cell Hemangioblastoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Paraganglioma Adenoma Pancreatic Neoplasms Digestive System Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Neurocutaneous Syndromes Nervous System Diseases |