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

NCT03768479 | Unknown

• 1 other identifier: XJTU1AF-CRF-2016-020
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Estrogen Receptor-positive Breast Cancer; Fulvestrant

Outcome Measures

Primary Outcomes (1)

• the change percentage of 18F-FES SUV

  The change percentage of 18F-FES standard uptake value (SUV) before and after cycle 1 of Fulvestrant treatment

  At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)

Secondary Outcomes (1)

• The correlation between the change percentage of 18F-FES SUV and the clinical efficacy

  From the enrollment time to the time of disease progression or 2 years' followup which comes first

Other Outcomes (1)

• clinical efficacy: RECIST criteria

  From the enrollment time to the time of disease progression or 2 years' followup which comes first

Study Arms (1)

FES-Fulvestrant

EXPERIMENTAL

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

Interventions

18F-FES-PET DEVICE

18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant

FES-Fulvestrant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 25380844 RESULT

Study Officials

• Jin Yang

  First Affiliated Hospital of Xi'an Jiaotong U

  PRINCIPAL INVESTIGATOR

• Jin Jin

  First Affiliated Hospital of Xi'an Jiaotong U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Yang

CONTACT

0086-029-85324600; yangjin@xjtu.edu.cn

Jin Jin

CONTACT

0086-029-85324600; yangjin@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 7, 2018
• Study Start: March 5, 2017
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-06

Locations

CN (1)