TheranosticTrials.org

Clinical Trial · NCT00956163

Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer

Overview

This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.

Sponsor

National Cancer Institute

Phase

Early Phase 1

Contacts

Mukesh Harisinghani (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00956163

Drug / Compound

methylene diphosphonate

Isotope(s):
Target(s):
  • Bone Metabolism
Ligand Class: Small Molecules

sodium fluoride

Isotope(s):
Target(s):
  • Bone Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Rising prostate-specific antigen (PSA) despite androgen deprivation therapy (ADT), PSA \> 10 ng/mL
  • * Any ethnic group
  • Patients Eastern Cooperative Oncology Group (ECOG) performance is =\< 1
  • Ability to understand and the willingness to sign a written combined Health Insurance Portability and Accountability Act (HIPAA) and informed consent document
  • Pathologically proven prostate cancer with high risk for bone metastases

Exclusion

  • 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 in this category are excluded to reduce medical risk to their safety and to avoid confounding variables in regard to the possibility of adverse events
  • Patients with known contraindications to MR imaging such as presence of MRI incompatible devices such as pacemakers and certain aneurysm clips, severe claustrophobia, or any other condition which would preclude proximity to a strong magnetic field; this exclusion is a standard of practice
  • Patient is unable to tolerate or has a lifer threatening allergy to the radiopharmaceutical used for bone scan or 18F-fluoride PET
  • * Patients may not receive any other investigational therapeutic agents from within 7 days prior to study drug administration through 7 days following study drug administration