Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
- Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. They want to test if the study drug can be used along with imaging devices to detect NETs.
- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown primary and metastatic NETs in the gastrointestinal system and pancreas.
- Adults over 10 years old with a suspected NET or family history of NET.
- Participants will be screened with a medical history and physical exam, and have a blood test.
- Participants will undergo three scans. For all of these, a substance is injected into their body, they lie on a table, and a machine takes images.
<TAB>- A standard CT scan of the chest, abdomen, and pelvis.
<TAB>- An octreotide scintigraphy SPECT/CT.
<TAB>- A 68Gallium-DOTATATE PET/CT. The study drug is injected into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device takes images of the body. The entire session takes 90 to 120 minutes.
- Researchers will compare images from the three scans.
- Participants will have 1 follow-up visit each year for 5 years. At this visit, they will have a medical exam, blood taken, and a CT scan.
|Neuroendocrine Tumors Von Hippel-Lindau Syndrome Hippel-Lindau Disease||Drug: 68Gallium DOTATATE Procedure: Radio-guided surgery||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors|
- To assess the diagnostic accuracy of the new imaging technique (68)Gallium-DOTATATE PET/CT scan for patients with NETs [ Time Frame: 3 years ]
|Study Start Date:||August 20, 2013|
|Estimated Study Completion Date:||December 3, 2022|
|Estimated Primary Completion Date:||January 1, 2021 (Final data collection date for primary outcome measure)|
68Gallium DOTATATE imaging
Drug: 68Gallium DOTATATE
Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.Procedure: Radio-guided surgery
Using 68Gallium DOTATATE
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967537
|Contact: Roxanne E Merkel||(240) email@example.com|
|Contact: Electron Kebebew, M.D.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Kaitlyn Chambers 301-402-4395 email@example.com|
|Contact: Roxanne Merkel (301) 402-4395 firstname.lastname@example.org|
|Principal Investigator:||Electron Kebebew, M.D.||National Cancer Institute (NCI)|