Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients
In this study, we propose to use a well-established PET isotope, 68-Gallium (68Ga), bound to
a somatostatin analogue, DOTA-octreotate, or DOTATATE, which has high affinity for the
somatostatin receptor type 2 (SSTR2). Most gastro-entero-pancreatic (GEP) NETs express SSTR2
on their cell surfaces; when the radiolabeled SSTR2 analogue binds to these receptors, the
radioactive molecule is internalized and transported to the tumor cell nucleus, thus
concentrating the radioactivity and improving the signal-to-noise ratio on the PET scan,
particularly as the background rapidly clears. This internalization, combined with the
improved physical principles of PET imaging, shorter half-life of the 68Ga (68 minutes vs.
about three days for 111In), improved radiation dosimetry, faster scanning, and lower cost
results in a greatly improved scan for diagnosis, staging and restaging of NET disease
compared to conventional 111In-octreotide imaging. Additionally, 68Ga-DOTATATE PET/CT
scanning can be performed in 1.5 hours from injection of the radiopharmaceutical to
completion of the scan, vs. 2-3 days for 111In-octreotide imaging.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Measure the number of adverse events in patients receiving Ga68-DOTATATE PET
We'll assess the safety and tolerability of Ga68-DOTATATE PET
3 years
Yes
Johannes Czernin, MD
Principal Investigator
University of California, Los Angeles
United States: Food and Drug Administration
DOTATATE12-001920
NCT01873248
May 2013
May 2017
Name | Location |
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University of California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology | Los Angeles, California 90095 |