68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Brief Summary

Official Title: “68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors”

Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: October 2013

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Scan
    • We will perform 68Ga-DOTATATE PET scans on subjects

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: One year
      Safety Issue?: Yes

Secondary Measures

  • Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques
    • Time Frame: one year
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Known diagnosis of neuroendocrine tumor
  • At least 18 years of age
  • Able to provide informed consent
  • Karnofsky score greater than 50
  • Females of childbearing potential must have a negative pregnancy test at screening/baseline

Exclusion Criteria

  • Serum creatinine >3.0 mg/dL (270 μM/L)
  • Hepatic enzyme levels more than 5 times upper limit of normal.
  • Known severe allergy or hypersensitivity to IV radiographic contrast.
  • 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 (e.g. cough, severe arthritis, etc.).
  • 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Vanderbilt University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eric H Liu, Assistant Professor – Vanderbilt University

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01396382