TheranosticTrials.org

Clinical Trial · NCT01320787

18-F-Fluoroacetate as PET Imaging Agent

Overview

The goal of this clinical research study is to find out the highest tolerable dose of an imaging solution called 18-F-fluoroacetate sodium that can be given before a positron emission tomography (PET) scan. The safety of this solution will also be studied.

Sponsor

MD Anderson Cancer Center

Phase

Phase 1

Contacts

Donald Podoloff, MD, BA (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01320787

Drug / Compound

fluoroacetate

Isotope(s):
Target(s):
  • Lipid/fatty acid synthesis
Ligand Class: Small Molecules

Eligibility

Inclusion

  • The Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 or Karnofsky Performance Status of ≥ 60.
  • 1. Patients must have: a) Histologic or cytologic confirmation of adenocarcinoma of the prostate; or b) A histologically confirmed, treatment-naïve, locally advanced breast cancer that express either estrogen receptor (ER) or progesterone receptor (PR) and are negative for ErbB2 by Immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH) gene amplification; or c) Suspected supratentorial malignant primary or secondary malignant tumor of the central nervous system (CNS).
  • Subjects must be at least 18 years of age
  • Four weeks or greater since major surgery.
  • Required Initial Laboratory Data: a) White Blood Count (WBC) \>/= 3,000/microliters. b) Absolute neutrophil count (ANC) \>/= 1,500/microliters. c) Platelet count \>/= 100,000/microliters. d) Creatinine \</= 1.5 x upper limit of normal e) Bilirubin \</= 2 x upper limit of normal (exceptions will be made for patients with Gilbert's Disease). f) SGOT (AST) \</= 2.5 x upper limit of normal. g) SGPT (ALT) \</= 2.5 x upper limit of normal.

Exclusion

  • 1. Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months) are excluded.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients may not be receiving any other investigational agents while on this protocol.
  • Patients with prostate cancer may not be receiving dutasteride or finasteride up to 2 weeks prior to enrollment.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition (i.e. 18F-FDG)