Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT01396382
Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Nashville, Tennessee, 37232, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.
Time frame: at 1 year
Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).
Time frame: at 1 year
Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.
Vanderbilt-Ingram Cancer Center
Other
Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors
Acronym: 68Ga
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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