Neuroendocrine Tumors Clinical Trial
Official title:
Evaluation of the Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors
Background: People with von Hippel-Lindau (VHL) can have problems with a variety of organs, such as the pancreas. The disease can cause tumors of the pancreas. This can result in life-threatening complications. Researchers want to learn more about these pancreatic tumors and how to better detect them. This may help them design better future treatment and care for people with VHL disease. Objective: To better understand VHL disease that affects the pancreas and to test whether adding a certain type of scan (68-Gallium DOTATATE PET/CT) can further detect tumors. Eligibility: People ages 12 and older with VHL that causes tumors and cysts to grow in the pancreas Design: Participants will be screened with their medical records and imaging studies. Participants will have an initial evaluation: Participants will have their body examined by different doctors. This will depend on what types of symptoms they have. Participants will have blood and urine tests Participants will have images made of their body using one or more machines: They made have a CT or PET/CT scan in which they lie on a table that moves through a big ring. They may have an MRI in which they lie on a table that moves into a big tube. They may have an ultrasound that uses a small stick that produces sound waves to look at the body. After the first visit, participants will be asked to return to the NIH. Some of the tests performed at the first visit will be repeated. Depending on their disease status, visits will be once a year or every 2 years for life.
Status | Recruiting |
Enrollment | 740 |
Est. completion date | July 1, 2036 |
Est. primary completion date | January 30, 2036 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | - INCLUSION CRITIERIA: 1. Subjects who have been diagnosed with VHL using the following criteria: -- Identification of a heterozygous germline pathogenic variant in VHL by molecular genetic testing. or -- Clinical criteria 2. Subjects with at least 1 pancreatic manifestation of VHL as documented on any non-invasive imaging study. These manifestations may include: - Pancreatic cyst(s) - Solid lesions suspicious for microcystic adenoma(s) - Solid enhancing lesions suspicious for PNET(s) - Any other solid lesion(s) of the pancreas 3. Age greater than or equal to 12 years. 4. Ability of subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: 1. Inability of subject to undergo serial non-invasive imaging. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterization of the natural and clinical histories of VHL pancreatic neuroendocrine tumors and cystic lesions | Characterization of the natural and clinical histories of VHL pancreatic neuroendocrine tumors and cystic lesions | 15 years | |
Secondary | predictive value of 68-Gallium DOTATATE PET/CT imaging in patient population | mean uptake between these two groups of adult patients in which per patient uptake is defined as the average uptake of multiple lesions detected in each patient | at each scheduled visit | |
Secondary | growth rate in solid pancreatic tumors | graded tumor biopsy | at each scheduled visit | |
Secondary | distribution of time from initial presentation with pancreatic tumors to the time that surgery is recommended | median amount of time from initial presentation with pancreatic tumors to the time that surgery is recommended | at each scheduled visit, until surgery is recommended |
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