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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Johannes Czernin, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01873248
First received: June 3, 2013
Last updated: April 12, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Neuroendocrine Carcinoma
Drug: 68Ga-DOTATATE PET Scan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

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


Secondary Outcome Measures:
  • Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT).


Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostics with PET
68Ga-DOTATATE PET scans will be performed on subjects
Drug: 68Ga-DOTATATE PET Scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01873248

Locations
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
University of California, Los Angeles
Investigators
Principal Investigator: Johannes Czernin, MD University of California, Los Angeles
  More Information

Additional Information:
Publications:

Responsible Party: Johannes Czernin, M.D. Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01873248     History of Changes
Other Study ID Numbers: DOTATATE12-001920
Study First Received: June 3, 2013
Last Updated: April 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Neuroendocrine Carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 29, 2014