An interventional study of 18F-FES-PET in Estrogen Receptor-positive Breast Cancer and Fulvestrant, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Other
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).
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.
First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
General Exclusion Criteria
General PET/CT Safety Exclusion Criteria:
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
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
Time frame: At end of cycle 1 of Fulvestrant treatment (each cycle is 28 days)
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
Time frame: From the enrollment time to the time of disease progression or 2 years' followup which comes first
clinical efficacy: RECIST criteria
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
Plan to share: Undecided
Started Mar 2017 (actual). Primary completion is estimated for Dec 2018, 21 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital Xi'an Jiaotong University →