TheranosticTrials.org

Clinical Trial · NCT02193672

A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy

Overview

The goal of this clinical research study is to find out if using the tracer (liquid used in imaging scans) \[18F\]fluciclatide in positron emission tomography / computed tomography (PET/CT) scans will help researchers learn more quickly if the disease is responding to treatment.

Sponsor

MD Anderson Cancer Center

Phase

Phase 1

Contacts

Apostolia M. Tsimberidou, MD,PHD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02193672

Drug / Compound

Fluciclatide

Isotope(s):
Target(s):
  • αvβ3
Ligand Class: Small Proteins and Antibody Fragments

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patient must have normal hepatic and renal function defined as: 1) AST (SGOT)/ALT (SGPT) \</=3 x institutional upper limit of normal and 2) serum creatinine \</= 2x institutional upper limit of normal.
  • Patient must be scheduled to receive an anti-VEGF inhibitor (bevacizumab, sorafenib, sunitinib, other), mTOR inhibitor (temsirolimus, everolimus, other), or other molecules with antiangiogenic properties including taxol as anti-cancer therapy.
  • Patient or patient's legally authorized representative provides written informed consent and is willing to comply with protocol requirements.
  • Platelet count of \> 75 x 10\^3/μL
  • 1. Patient is \>/= 18 years and male or female of any race/ethnicity.

Exclusion

  • Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following: 1) Confirming in medical history that the patient is postmenopausal defined as 12 consecutive months of amenorrhea, or surgically sterile, 2) Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: Intrauterine device (IUD), oral contraceptives, Depo-Provera, or Norplant, 3) Confirming a negative urine dipstick test taken the morning of receiving the investigational agent \[18F\]fluciclatide.
  • 1. Patient is not capable of complying with study procedures.