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

Primary Purpose

Estrogen Receptor-positive Breast Cancer, Fulvestrant

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

18F-FES-PET

About this trial

This is an interventional other trial for Estrogen Receptor-positive Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES-Fulvestrant

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT03768479

First Posted

November 26, 2018

Last Updated

December 9, 2018

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT03768479

Brief Title

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

Acronym

PET

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 5, 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Estrogen Receptor-positive Breast Cancer, Fulvestrant

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FES-Fulvestrant

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

18F-FES-PET

Intervention Description

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

Primary Outcome Measure Information:

Title

the change percentage of 18F-FES SUV

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

clinical efficacy: RECIST criteria

Description

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

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Yang

Phone

0086-029-85324600

yangjin@xjtu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Jin

Phone

0086-029-85324600

yangjin@xjtu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin Yang

Organizational Affiliation

First Affiliated Hospital of Xi'an Jiaotong U

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jin Jin

Organizational Affiliation

First Affiliated Hospital of Xi'an Jiaotong U

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Xi'an Jiaotong University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Yang

Phone

0086-029-85324600

yangjin@xjtu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25380844

Citation

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.

Results Reference

result

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

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