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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01873248
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : May 13, 2021
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This is a prospective, Phase 1-2, single center study in a total of 100 subjects with Neuroendocrine Tumors (NETs). Study participants will receive a one-time administration of 68Ga-DOTATATE and undergo a PET/CT imaging study, to investigate its suitability as a PET imaging agent for NETs.

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma Drug: 68Ga-DOTATATE Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients
Actual Study Start Date : August 26, 2013
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : June 16, 2017

Arm Intervention/treatment
Experimental: Diagnostics with PET
68Ga-DOTATATE PET scans will be performed on subjects
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.
Other Name: 68Ga-DOTATATE PET/CT scan

Primary Outcome Measures :
  1. Measure the number of adverse events in patients receiving Ga68-DOTATATE PET [ Time Frame: 3 years ]
    We'll assess the safety and tolerability of Ga68-DOTATATE PET

Secondary Outcome Measures :
  1. Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques [ Time Frame: 3 Years ]
    We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 screening/baseline.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01873248

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United States, California
University of California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
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Principal Investigator: Johannes Czernin, MD University of California, Los Angeles
Additional Information:

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Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT01873248    
Other Study ID Numbers: 12-001920
DOTATATE12-001920 ( Other Identifier: Jonsson Comprehensive Cancer Center )
NCI-2016-01796 ( Registry Identifier: CTRP )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jonsson Comprehensive Cancer Center:
Neuroendocrine Carcinoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue