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

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ClinicalTrials.gov Identifier: NCT03768479
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Estrogen Receptor-positive Breast Cancer Fulvestrant Device: 18F-FES-PET Not Applicable

Detailed Description:

This study is an open, multi-center and prospective clinical study, It is the first time investigators are examining this imaging agent in Chinese patients with breast cancer.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Value of 18F-FES-PET/CT in Predicting the Efficacy of Fulvestrant as First-line Treatment in Postmenopausal Patients With Hormone Receptor-positive Advanced Breast Cancer - a Multicenter Prospective Study
Actual Study Start Date : March 5, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: 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.
Device: 18F-FES-PET
18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant




Primary Outcome Measures :
  1. the change percentage of 18F-FES SUV [ Time Frame: At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days) ]
    The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment


Secondary Outcome Measures :
  1. The correlation between the change percentage of 18F-FES SUV and the clinical efficacy [ Time Frame: From the enrollment time to the time of disease progression or 2 years' followup which comes first ]
    To find the correlation between the change percentage of 18F-FES SUV and the clinical efficacy, and further to determine the cutoff of 18F-FES SUV change percentage that could predict beneficial efficacy of Fulvestrant in breast cancer


Other Outcome Measures:
  1. clinical efficacy: RECIST criteria [ Time Frame: From the enrollment time to the time of disease progression or 2 years' followup which comes first ]
    The therapeutic efficacy of Fulvestrant in breast cancer patients, record as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to RECIST criteria



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 18 years or older (required for legal consent)
  • 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:

General Exclusion Criteria

  • Previously treated metastatic breast cancer
  • 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)

General PET/CT Safety Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768479


Contacts
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Contact: Jin Yang 0086-029-85324600 yangjin@xjtu.edu.cn
Contact: Jin Jin 0086-029-85324600 yangjin@xjtu.edu.cn

Locations
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China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Jin Yang    0086-029-85324600    yangjin@xjtu.edu.cn   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Jin Yang First Affiliated Hospital of Xi'an Jiaotong U
Principal Investigator: Jin Jin First Affiliated Hospital of Xi'an Jiaotong U

Publications of Results:
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03768479     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2016-020
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs