None listed
Conditions
Brief summary
This is a pilot study investigating the use of oestradiol PET scanning (FES-PET) in helping to assess hormone receptor positive metastatic breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, of any gender, and you have been diagnosed with ER positive metastatic breast cancer. Study details All participants will undergo upto three oestradiol PET scans. Each scan will take less than 30 minutes. There will be one scan at enrolment, at 2 months, and at 6 months later. However if the first scan does not show any disease subsequent FES PET scans will not be undertaken. Participants will also receive standard FDG PET scans, as per usual care. Data relating to your care, treatment, outcome and your demographic information will be obtained from case notes. It is hoped this research will reveal whether FES-PET is useful in providing information about disease progress and treatment response in ER positive metastatic breast cancer, and help to improve future clinical diagnosis and monitoring.
Interventions
Oestradiol PET scan following informed consent along with FDG-PET scan. The appointment will be arranged with the patient. If the baseline oestradiol PET does not show any disease the patient will return to standard imaging. If the baseline oestradiol PET shows disease and the FDG PET scan does not the patient will have an FES-PET at 2 months along with CT scan if visceral disease and then a further FES-PET scan as well as CT scan if visceral disease. If the baseline oestradiol PET and the FDG-PET both show disease there will be follow-up PET scans (both oestradiol and standard PET scan) at 2 months and at 6 months. The scans will last less than 30 minutes. There will be injection of the tracers FES and FDG for the PETs cans intravenously. The results will be used for study purposes but also potentially to guide patient management.
Sponsors
Eligibility
Inclusion criteria
ER positive metastatic breast cancer patient as defined as IHC >30% for ER who are either treatment naïve in the metastatic setting, or who have been determined to have progressed on previous treatment and are planned to commence a further line of treatment. Those with either ductal or lobular subtype will be included. The number of ductal patients included will be capped at five.
Exclusion criteria
Life expectancy less than 6 months, unable to give informed consent, unable to comply with required scanning schedule. May include conditions that increase the risk to the participant, that interfere with the participants ability to give informed consent or interfere with a participant’s ability to comply.