Von Hippel-Lindau DiseaseVHLimageNCT00970970
Visualizing Vascular Endothelial Growth Factor (VEGF) Producing Lesions in Von Hippel-Lindau Disease
An observational study of Von Hippel-Lindau Disease and Hemangioblastoma, run by University Medical Center Groningen at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Von Hippel-Lindau Disease, Hemangioblastoma, Renal Cell Carcinoma
- What is being tested?
- 89Zr bevacizumab PET scan
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from a tertiary referral center for Von Hippel-Lindau disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Von Hippel-Lindau Disease, Hemangioblastoma, Renal Cell Carcinoma, Pheochromocytoma, Pancreatic Neuroendocrine Tumor
- Being tested
- 89Zr bevacizumab PET scan
- Keywords
- Vascular endothelial growth factor, von Hippel Lindau disease, molecular imaging, biomarker
- Medical subject headings
- von Hippel-Lindau Disease, Hemangioblastoma, Carcinoma, Renal Cell, Pheochromocytoma, Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr bevacizumab PET scanOther
Also called VEGF imaging
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.
| Study group | Role | What they receive |
|---|---|---|
| Von Hippel Lindau | Adult patients with Von Hippel-Lindau disease Receives: Other: 89Zr bevacizumab PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of VHL associated lesions with 89Zr-bevacizumab PET scans in patients with VHLD
Measured: An 89Zr-bevacizumab PET scan will be performed within 6 weeks after routine MRI CNS investigation, MRI will be repeated within 12 months.
Secondary outcomes (1)
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
Measured: The baseline MRI scan will be compared with a follow-up MRI scan within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Hippel-Lindau DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- VHL Alliance
- Responsible party
- Sponsor
- Investigators
- Sjoukje Oosting, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970970
- Sponsor's protocol ID
- METc2009.119
- Acronym
- VHLimage
- Status last verified
- May 2024
- First submitted
- 2 Sep 2009
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualizing VEGF Producing Lesions in Von Hippel-Lindau Disease
- ClinicalTrials.gov ID
- NCT00970970
- Acronym / sponsor ID
- VHLimage / METc2009.119
- Conditions
- Von Hippel-Lindau Disease, Hemangioblastoma, Renal Cell Carcinoma, Pheochromocytoma, Pancreatic Neuroendocrine Tumor
- Keywords
- Vascular endothelial growth factor, von Hippel Lindau disease, molecular imaging, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- VHL Alliance
- Study start
- Sep 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Von Hippel Lindau | – | Other: 89Zr bevacizumab PET scanAdult patients with Von Hippel-Lindau disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from a tertiary referral center for Von Hippel-Lindau disease.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr bevacizumab PET scanAlso: VEGF imagingPatients 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 | Von Hippel Lindau |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sjoukje Oosting, MD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Hippel-Lindau Disease and Hemangioblastoma, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.