This study is currently recruiting participants.
Number
08-DK-0098
Sponsoring Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 100 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Children
Keywords
Neuroendocrine; PET; Gastrointestinal; Serotonin; Natural History
Recruitment Keyword(s)
Carcinoid Tumor; Gastrointestinal Carcinoid Tumor; Familial Cancer Tumor
Condition(s)
Carcinoid
Investigational Drug(s)
(18-F) DOPA
Investigational Device(s)
None
Intervention(s)
Drug: [18F]-DOPA
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
Members of families, including all siblings and offspring in which two or more immediate blood relatives have had small bowel carcinoid tumors are eligible for this study. In some cases unaffected spouses of family members diagnosed with carcinoid cancer are also requested to participate by donating a sample of blood only.
Participants undergo a medical evaluation every 3 years during a 3- to 5-day hospital stay at the NIH Clinical Center. All participants have a personal and family medical history obtained and undergo a physical examination, blood and urine tests.
People who already have a small bowel carcinoid tumor or are at risk of developing a carcinoid tumor have some or all of the following procedures to determine the presence of carcinoid tumor and its (omit next two words- location or) spread to other areas of the body:
-Video Capsule Endoscopy: Visualization of the gastrointestinal tract by ingesting a disposable, "vitamin-pill sized" video capsule that has its own camera and light source.
-CT of the chest abdomen and pelvis with oral and IV contrast : X-ray examination of the chest, abdominal and pelvis organs.
-18 FDOPA Positron emission tomography (PET) with CT for localization: Nuclear imaging scan to look at tumor activity.
-MRI Liver with contrast - to determine if disease has spread to liver
-Gallium 68 PET/CT-limited to individuals that have residual tumor.
-Clinical and research blood work
Should mid gut carcinoid tumors be found every participant will be assisted in determine what the best course of treatment will be for them.
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INCLUSION CRITERIA: There are four types of participants who will be included in this protocol as outlined below. In order to be eligible to participate in this study, an individual must meet all of the following criteria for their group: Group 1 (Arm 1 or Arm 2) -Male and female subjects >= 18 years of age -Have a diagnosis of small intestinal carcinoid tumor -Have at least one blood relation with a diagnosis of either small intestinal, pulmonary, kidney or gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary Group 2 (Arm 1 or Arm 2) -Male and female subjects >= 18 years of age -Has multiple synchronous primary small intestinal tumors Group 3 (Arm 1 or Arm 2) -Male and female subjects >=18 years of age -Does not have a diagnosis of carcinoid tumor -Has one of the following: --at least two blood relatives with any combination of diagnoses of small intestinal carcinoid tumor, a pulmonary, kidney, gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary OR --has at least one blood relative with multiple, synchronous primary small bowel tumors Group 4 (Arm 2 only) -Male and female subjects >= 18 years of age -Not biologically related to the participating family but has offspring who is/are blood relative(s) of a participating subject. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Members of families with multiple endocrine neoplasia (MEN) I, MEN II or other familial tumor syndromes such as Von Hippel Lindau Syndrome and Neurofibromatosis type I and type II for which there is a known genetic predisposition to non-carcinoid tumors as well as carcinoid tumors will be excluded from the study. 2. Any condition which, in the opinion of the investigator, would make it unsafe to participate or would prohibit completion of the protocol. 3. Inability to provide informed consent (Arm 1 only) 4. Pregnant or breastfeeding (Arm 1 only)
There are four types of participants who will be included in this protocol as outlined below.
In order to be eligible to participate in this study, an individual must meet all of the following criteria for their group:
Group 1 (Arm 1 or Arm 2)
-Male and female subjects >= 18 years of age
-Have a diagnosis of small intestinal carcinoid tumor
-Have at least one blood relation with a diagnosis of either small intestinal, pulmonary, kidney or gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary
Group 2 (Arm 1 or Arm 2)
-Has multiple synchronous primary small intestinal tumors
Group 3 (Arm 1 or Arm 2)
-Male and female subjects >=18 years of age
-Does not have a diagnosis of carcinoid tumor
-Has one of the following:
--at least two blood relatives with any combination of diagnoses of small intestinal carcinoid tumor, a pulmonary, kidney, gastropancreatic neuroendocrine tumor or metastatic neuroendocrine tumor of unknown primary OR
--has at least one blood relative with multiple, synchronous primary small bowel tumors
Group 4 (Arm 2 only)
-Not biologically related to the participating family but has offspring who is/are blood relative(s) of a participating subject.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this
study:
1. Members of families with multiple endocrine neoplasia (MEN) I, MEN II or other familial tumor syndromes such as Von Hippel Lindau Syndrome and Neurofibromatosis type I and type II for which there is a known genetic predisposition to non-carcinoid tumors as well as
carcinoid tumors will be excluded from the study.
2. Any condition which, in the opinion of the investigator, would make it unsafe to participate or would prohibit completion of the protocol.
3. Inability to provide informed consent (Arm 1 only)
4. Pregnant or breastfeeding (Arm 1 only)
Principal Investigator
Referral Contact
For more information: