TheranosticTrials.org

Clinical Trial · NCT03768479

The Value of 18F-FES-PET/CT in Predicting Fulvestrant Efficacy in Breast Cancer

Overview

This study is focused on the value of 18F-FES-PET in predicting the Fulvestrant efficacy in hormone receptor-positive breast cancer. The imaging agent involved in this study is 16α-\[18F\]-fluoro-17β-estradiol (18F-FES).

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Phase

N/A

Contacts

Jin Yang (CONTACT)

yangjin@xjtu.edu.cn

0086-029-85324600

Jin Jin (PRINCIPAL_INVESTIGATOR)

Jin Yang (PRINCIPAL_INVESTIGATOR)

Jin Jin (CONTACT)

yangjin@xjtu.edu.cn

0086-029-85324600

ClinicalTrials.gov

NCT03768479

Drug / Compound

FES

Isotope(s):
Target(s):
  • Estrogen Receptor
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Have primary breast tumor that is at least 2 cm in diameter as measured in any dimension on either mammogram, ultrasound, or breast MRI
  • Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Pathologically diagnosed metastatic breast cancer
  • Fulvestrant used as the first-line treatment

Exclusion

  • Currently lactating (either breast feeding or breast pumping)General PET/CT Safety Exclusion Criteria:
  • Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing
  • Impaired elimination (as defined as having problems with urination)
  • Electrical implants such as cardiac pacemakers or perfusion pumps
  • Participation in a research study/studies involving radiation exposure within the past 12 months
  • Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
  • Concurrent malignancy of any type
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, major kidney or liver disease, or psychiatric illness/social situations that would limit compliance with study requirements
  • Inability to lie comfortably on a bed inside a PET camera for 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis)
  • Previously treated metastatic breast cancer
  • General Exclusion Criteria
  • Pregnancy