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
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor-positive Breast Cancer Fulvestrant||Device: 18F-FES-PET||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant
- 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
- 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
- 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
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
|Contact: Jin Yangfirstname.lastname@example.org|
|Contact: Jin Jinemail@example.com|
|The First Affiliated Hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Jin Yang 0086-029-85324600 firstname.lastname@example.org|
|Principal Investigator:||Jin Yang||First Affiliated Hospital of Xi'an Jiaotong U|
|Principal Investigator:||Jin Jin||First Affiliated Hospital of Xi'an Jiaotong U|