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Protocol Details

Evaluation of the Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-C-0135

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 12 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Pancreatic tumors;
68-Gallium DOTATATE;
MEN1 syndrome;
NETest;
PNET

Recruitment Keyword(s)

None

Condition(s)

VHL pancreatic neuroendocrine tumors;
Von Hippel-Lindau Disease;
Neuroendocrine Tumors

Investigational Drug(s)

68- Gallium DOTATATE

Investigational Device(s)

None

Intervention(s)

Drug: 68-Gallium DOTATATE

Supporting Site

National Cancer Institute

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.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Naris Nilubol, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5952
10 CENTER DR
BETHESDA MD 20892
(240) 760-6154
niluboln@mail.nih.gov

Kristine J. Villaruel
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D19
10 Center Drive
Bethesda, Maryland 20892
(240) 858-7033
kristinejoy.villaruel@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT04074135

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