Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vanderbilt-Ingram Cancer Center
Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 68GaDOTATATE and undergo a PET/CT imaging study. Scans will be performed with "negative" oral contrast (e.g. Volumen™ or equivalent), as many NETs involve the GI tract.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Known diagnosis of neuroendocrine tumor
At least 18 years of age
Able to provide informed consent
Karnofsky score greater than 50
Females of childbearing potential must have a negative pregnancy test at screening/baseline
You may not be if
Serum creatinine \>3.0 mg/dL (270 μM/L)
Hepatic enzyme levels more than 5 times upper limit of normal.
Known severe allergy or hypersensitivity to IV radiographic contrast.
Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Recognized concurrent active infection
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
