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Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation

NCT03544762 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-05-30

No results posted yet for this study

Summary

The propose of this prospective study focuses on the role of \[18F\]FES PET imaging in patients with breast cancer who might receive or are receiving hormone therapy. First, we will develop and optimize the radiosynthesis and quality control tests of \[18F\]FES in conditions that meet good manufacturing practice (GMP) requirements. Secondly, patients with or without metastatic breast cancer will be enrolled for the conduction of human study. \[18F\]FES PET imaging will be performed on patients before the initiation of hormone therapy to predict the prognosis and therapeutic response to hormone therapy. The \[18F\]FES PET results will be compared with ER status obtained by immunohistochemical (IHC) staining on surgically obtained specimens. Moreover, in patients with progression of metastatic disease, the \[18F\]FES PET will be correlated with ESR1 gene mutation, which is one of the mechanisms for resistance to hormone therapy.

Conditions

Interventions

DRUG

18F-FES PET

18F-FES PET will be performed for each patient. All patients will receive intravenously injection of 5-8 mCi (185-296 MBq) of 18F-FES. PET imaging will be performed on PET/CT system. The 1-frame dynamic data acquisition of thoracic region including the primary tumor will be started immediately after tracer injection. Whole-body PET acquisition from skull base to upper thigh will be started 60 minutes after tracre injection.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-08
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544762 on ClinicalTrials.gov