TheranosticTrials.org

Clinical Trial · NCT01396382

68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Overview

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.

Sponsor

Vanderbilt-Ingram Cancer Center

Phase

Phase 2

Contacts

Ronald C. Walker, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01396382

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Known diagnosis of neuroendocrine tumor
  • Females of childbearing potential must have a negative pregnancy test at screening/baseline
  • Karnofsky score greater than 50

Exclusion

  • Known severe allergy or hypersensitivity to IV radiographic contrast.
  • 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.).
  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
  • Hepatic enzyme levels more than 5 times upper limit of normal.
  • 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.
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Serum creatinine \>3.0 mg/dL (270 μM/L)
  • Recognized concurrent active infection