Diagnostic Accuracy and Safety Study of FES PET/CT in Assessment of ER Status of Recurrent or Metastatic Breast Cancer
NCT ID: NCT01986569
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
93 participants
INTERVENTIONAL
2013-11-30
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[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.
[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.
Interventions
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[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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Dae Hyuk Moon
Professor
Principal Investigators
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Dae Hyuk Moon, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Chae SY, Ahn SH, Kim SB, Han S, Lee SH, Oh SJ, Lee SJ, Kim HJ, Ko BS, Lee JW, Son BH, Kim J, Ahn JH, Jung KH, Kim JE, Kim SY, Choi WJ, Shin HJ, Gong G, Lee HS, Lee JB, Moon DH. Diagnostic accuracy and safety of 16alpha-[18F]fluoro-17beta-oestradiol PET-CT for the assessment of oestrogen receptor status in recurrent or metastatic lesions in patients with breast cancer: a prospective cohort study. Lancet Oncol. 2019 Apr;20(4):546-555. doi: 10.1016/S1470-2045(18)30936-7. Epub 2019 Mar 4.
Related Links
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Genetics Home Reference related topics; breast cancer
MedlinePlus related topics; Breast cancer
Other Identifiers
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FES13001
Identifier Type: -
Identifier Source: org_study_id