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Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

Phase 1/Phase 2
18 Years
Open (Enrolling)
Neuroendocrine Carcinoma

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Trial Information

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.

Inclusion Criteria:

- Known diagnosis of NET, suspected SSTR positive tumors or suspected NET recurrence.

- At least 18 years of age.

- Patient or patient's legally acceptable representative cognitively provides written
informed consent.

- Able to provide informed consent.

- Females of childbearing potential must have a negative pregnancy test at

Exclusion Criteria:

- 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.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Measure the number of adverse events in patients receiving Ga68-DOTATATE PET

Outcome Description:

We'll assess the safety and tolerability of Ga68-DOTATATE PET

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Johannes Czernin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Los Angeles


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

May 2017

Related Keywords:

  • Neuroendocrine Carcinoma
  • Neuroendocrine Carcinoma
  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors



University of California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology Los Angeles, California  90095