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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01873248
Collaborator
(none)
238
Enrollment
1
Location
1
Arm
45.7
Actual Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Aug 26, 2013
Actual Primary Completion Date :
Jun 16, 2017
Actual Study Completion Date :
Jun 16, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostics with PET

68Ga-DOTATATE PET scans will be performed on subjects

Drug: 68Ga-DOTATATE
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.
Other Names:
  • 68Ga-DOTATATE PET/CT scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measure the number of adverse events in patients receiving Ga68-DOTATATE PET [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 [3 Years]

      We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Investigators

    • Principal Investigator: Johannes Czernin, MD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01873248
    Other Study ID Numbers:
    • 12-001920
    • DOTATATE12-001920
    • NCI-2016-01796
    First Posted:
    Jun 10, 2013
    Last Update Posted:
    May 13, 2021
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Jonsson Comprehensive Cancer Center
    Neuroendocrine Carcinoma
    Additional relevant MeSH terms:
    Neuroendocrine Tumors
    Carcinoma, Neuroendocrine

    Study Results

    No Results Posted as of May 13, 2021