Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer

December 7, 2016 updated by: Dae Hyuk Moon, Asan Medical Center

A Phase III, Open Label, Non-randomized, Single Center Study to Evaluate Diagnostic Accuracy and Safety of Fluorine-18 (18F) Fluoroestradiol PET/CT in the Assessment of ER Status of Recurrent or Metastatic Lesions in Patients With Breast Cancer

The standard diagnostic workup for recurrent or metastatic breast cancer includes biopsy and determination of tumor estrogen status according to National Comprehensive Cancer Network and European Society for Medical Oncology. Immunohistochemistry (IHC) is currently the most commonly used method for determining ER status. A investigational imaging tracer named 16-alpha-[18F]-fluoro-17-beta-estradiol, or [18F]fluoroestradiol ([18F]FES) acts similarly in vivo to estradiol and binds to estrogen receptors (ERs). Previous studies in human have shown the efficacy of [18F]FES PET in detecting ER positive breast cancer without any observed toxicity. The investigators hypothesized that [18F]FES PET imaging can noninvasively assess ER status in recurrent or metastatic breast cancer lesion . In this study, a positive and negative percent agreement between IHC and [18F]FES will be determined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A patient will be enrolled if the patient meets the following inclusion criteria

    1. Patient is ≥19 years of age and male or female of any race/ethnicity
    2. Patients has first recurrence or stage IV disease by American Joint Committee on Cancer tumor-node-metastasis staging system for breast cancer
    3. Patients had histologically confirmed invasive primary breast carcinoma and the documented results of histology are available.
    4. Patients are scheduled to undergo core needle biopsy or surgery for histological confirmation and determination of ER status of recurrent or distant metastatic cancer within 15 days after [18F]FES PET; or patients already underwent core needle biopsy of recurrent or distant metastatic cancer within 30 days before [18F]FES PET and biopsy specimens are available for determination of ER status.
    5. Discontinuation of selective ER blocking agents including tamoxifen or fulvestrant for at least 60 days prior to [18F]FES PET
    6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

Exclusion Criteria:

  • A patient will be excluded from this study if the patient does not full fulfill the inclusion criteria, or if any of the following conditions are observed

    1. Patient or patient's legally acceptable representative do not provide written informed consent
    2. The recurrent or metastatic lesion scheduled to undergo biopsy is located in breast, liver, ovary, uterus, or bone
    3. Female patient is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) woman is physiologically post menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a urine pregnancy test performed within 24 hours immediately prior to administration of [18F]FES has to be negative and the women is advised to apply contraceptive measures during her participation in this study
    4. Adjuvant chemotherapy within 3 weeks prior to [18F]FES PET.
    5. Radiation therapy or immuno/biologic therapy is scheduled to be given to patient before the histologic confirmation by biopsy or [18F]FES PET.
    6. Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) in the judgment of the investigator.
    7. Patient is a relative of the investigator, student of the investigator or otherwise dependent
    8. Patient has any other condition or personal circumstances that, in the judgment of the investigator, might interfere with the collection of complete data
    9. Patient has been involved in an investigative, radioactive research procedure within 7 days prior to registration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]fluoroestradiol (FES)
The injectable radioactive dose of 111-222 megabecquerel. One single IV injection over 1-2 min. [18F]FES PET/CT for imaging.
Drug: [18F]fluoroestradiol (FES)
[18F]FES PET/CT will be performed 90 min (± 10 min) after administration of [18F]FES. Patients will undergo core needle biopsy or surgery within 15 days after [18F]FES PET; or patients will undergo core needle biopsy within 30 days before [18F]FES PET. Experienced pathologists will determine metastatic/recurrent disease, and tumor histology including IHC. Patient will undergo surgery, radiation therapy or systemic therapy according to the results of staging workup, histology and biomarkers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lesion-level positive and negative percent agreement between qualitative [18F]FES PET interpretation and reference IHC testing
Time Frame: up to 3 years
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Dae Hyuk Moon, MD. PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FES13001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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