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

May 12, 2021 updated by: Jonsson Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2013

Primary Completion (Actual)

June 16, 2017

Study Completion (Actual)

June 16, 2017

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-001920
  • NCI-2016-01796 (Registry Identifier: CTRP)
  • DOTATATE12-001920 (Other Identifier: Jonsson Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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