The Value of 18F-FES-PET/CT in Predicting Fulvestrant Efficacy in Breast Cancer
NCT ID: NCT03768479
Last Updated: 2018-12-11
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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UNKNOWN
NA
68 participants
INTERVENTIONAL
2017-03-05
2019-03-31
Brief Summary
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Detailed Description
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The Chinese FDA has approved 18F-FES as an investigational tracer in a selective few research studies. The Chinese FDA has not approved this tracer for any use outside of research. In this research study, the investigators are investigating the use of a PET tracer called 18F-FES in patients with breast cancer.
The purpose is to take images that can measure the amount of a protein called Estrogen Receptor, or 'ER' in breast tumors. The expression level of ER is tightly correlated with the Fulvestrant efficacy in patients with breast cancer. The investigators will take the pictures of the participant's residual tumor lesions using a PET/CT scanner with 18F-FES used as the tracer before and after the first cycle of Fulvestrant treatment. The investigators are trying to clarify the relationship between the clinical Fulvestrant efficacy and the amount change of 18F-FES uptake by breast tumor around the first cycle of Fulvestrant treatment.
This could help them to predict the efficacy of endocrine therapy by monitoring the dynamic levels of ER in advance, and potentially help guide treatment of breast tumors in the future.
18F-FES was initially developed to image the primary breast tumor. In previous studies of 18F-FES conducted in humans, there were no adverse events (there have been no problems). While this is not the first time 18F-FES has been used in humans, it is the first study in which the investigators study its predictive value in the treatment efficacy in breast cancer.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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FES-Fulvestrant
Patients with ER positive breast cancer receive Fulvestrant as the first line treatment enrolled in the study would receive 18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant.
18F-FES-PET
18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant
Interventions
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18F-FES-PET
18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Concurrent malignancy of any type
* Impaired elimination (as defined as having problems with urination)
* Participation in a research study/studies involving radiation exposure within the past 12 months
* 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
* Pregnancy
* Currently lactating (either breast feeding or breast pumping)
* Electrical implants such as cardiac pacemakers or perfusion pumps
* 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
* Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
* 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)
* Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure for female subjects of child-bearing age.
18 Years
65 Years
FEMALE
No
Sponsors
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First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Jin Yang
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Xi'an Jiaotong U
Jin Jin
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Xi'an Jiaotong U
Locations
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Jin Yang
Role: primary
References
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van Kruchten M, de Vries EG, Glaudemans AW, van Lanschot MC, van Faassen M, Kema IP, Brown M, Schroder CP, de Vries EF, Hospers GA. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015 Jan;5(1):72-81. doi: 10.1158/2159-8290.CD-14-0697. Epub 2014 Nov 7.
Other Identifiers
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XJTU1AF-CRF-2016-020
Identifier Type: -
Identifier Source: org_study_id