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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase IDiagnosticClosed18 and overOtherDOTATATE12-001920
NCT01873248

Trial Description

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.

Further Study Information

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

Johannes CzerninPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01873248
ClinicalTrials.gov processed this data on October 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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