A Phase 2 interventional study of 68-Gallium DOTATATE in VHL Pancreatic Neuroendocrine Tumors, Von Hippel-Lindau Disease and Neuroendocrine Tumors, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Diagnostic
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.
Background:
Objective:
- To comprehensively and longitudinally evaluate the natural history of participants with VHL pancreatic neuroendocrine tumors and cystic lesions, estimating and defining their clinical spectrum.
Eligibility:
- Participants greater than or equal to 12 years of age diagnosed with VHL.
Design:
55 studies on the registry are indexed under von Hippel-Lindau Disease; 23 are open to participants now.
This study's planned enrollment of 740 is above the median of 28 across 31 interventional studies indexed under von Hippel-Lindau Disease.
Browse von Hippel-Lindau Disease studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants 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
Participants with at least 1 pancreatic manifestation of VHL as documented on any non-invasive imaging study. These manifestations may include:
EXCLUSION CRITERIA:
1. Inability of participant to undergo serial non-invasive imaging.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study natural history of VHL pancreatic neuroendocrine tumors with yearly 68-Gallium DOTATATE PET/CT research scans.
Drug: 68-Gallium DOTATATE
Study natural history of VHL pancreatic neuroendocrine tumors without research scans.
68-Gallium DOTATATE, to be used in yearly PET/CT research scans
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
Time frame: 15 years
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
Time frame: at each scheduled visit
growth rate in solid pancreatic tumors
graded tumor biopsy
Time frame: at each scheduled visit
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
Time frame: at each scheduled visit, until surgery is recommended
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.
Started Jun 2020 (actual). Primary completion is estimated for Jan 2036, 187 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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