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History of Changes for Study: NCT01986569
Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer
Latest version (submitted December 7, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 15, 2013 None (earliest Version on record)
2 November 18, 2013 Arms and Interventions, Outcome Measures, Study Status and Study Identification
3 January 13, 2015 Study Status, Contacts/Locations and Outcome Measures
4 December 30, 2015 Study Status
5 July 14, 2016 Study Status
6 December 7, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01986569
Submitted Date:  November 15, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: FES13001
Brief Title: Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer
Official Title: A Phase III, Open Label, Non-randomized, Single Center Study to Evaluate Diagnostic Accuracy and Safety of [18F]Fluoroestradiol PET/CT in the Assessment of ER Status of Recurrent or Metastatic Lesions in Patients With Breast Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2013
Overall Status: Recruiting
Study Start: November 2013
Primary Completion: November 2015 [Anticipated]
Study Completion: November 2015 [Anticipated]
First Submitted: November 12, 2013
First Submitted that
Met QC Criteria:
November 15, 2013
First Posted: November 18, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 15, 2013
Last Update Posted: November 18, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Asan Medical Center
Responsible Party: Principal Investigator
Investigator: Dae Hyuk Moon
Official Title: Professor
Affiliation: Asan Medical Center
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Recurrent Breast Cancer
Stage IV Breast Cancer
Keywords: Fluoroestradiol (FES)
PET/CT scan
Estrogen Receptor
Recurrent breast cancer
Stage IV breast cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 94 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Diagnostic FES PET/CT imaging
Drug: Fluoroestradiol (FES) Procedure: PET/CT for imaging
Drug: Fluoroestradiol (FES)
Procedure: PET/CT for imaging
Open or close this module Outcome Measures
Primary Outcome Measures:
1. lesion-level positive and negative percent agreement between qualitative [18F]FES PET interpretation and reference IHC testing
[ Time Frame: up to 1 month ]

Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Dae Hyuk Moon, MD. PhD.
Telephone: 82-2-3010-4592
Email: dhmoon@amc.seoul.kr
Central Contact Backup: Minjung Cho
Telephone: 82-2-3010-6273
Email: mjc@amc.seoul.kr
Study Officials: Dae Hyuk Moon, MD. PhD
Principal Investigator
Asan Medical Center
Locations: Korea, Republic of
Asan Medical Center
[Recruiting]
Seoul, Korea, Republic of, 138-736
Contact:Contact: Dae Hyuk Moon, MD. PhD 82-2-3010-4592 dhmoon@amc.seoul.kr
Contact:Principal Investigator: Dae Hyuk Moon, MD. PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Genetics Home Reference related topics; breast cancer
Description: MedlinePlus related topics; Breast cancer
Available IPD/Information:

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