Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001588886
Ethics application status
Approved
Date submitted
22/09/2021
Date registered
19/11/2021
Date last updated
21/10/2022
Date data sharing statement initially provided
19/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Oestradiol positron emission tomography (PET) scans in metastatic breast cancer:investigation of utility of assessing disease burden and treatment response
Scientific title
Oestradiol PET scans in metastatic breast cancer:investigation of utility of assessing disease burden and treatment response
Secondary ID [1] 305381 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
metastatic hormone receptor positive breast cancer 323732 0
Condition category
Condition code
Cancer 321261 321261 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 321791 0
Diagnosis / Prognosis
Comparator / control treatment
FDG PET scans
Control group
Active

Outcomes
Primary outcome [1] 329044 0
Comparison of information obtained between oestradiol and standard FDG PET scan at time of initial investigation
Timepoint [1] 329044 0
baseline (during diagnostic workup)
Secondary outcome [1] 401259 0
Comparison of information obtained between oestradiol and standard FDG PET scan on follow-up assessment to assess response
Timepoint [1] 401259 0
2 and 6 month follow-up

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis as small pilot study. If additional information is found for at least 1 patient with either lobular or ductal breast cancer or additional information regarding response assessment the study will be expanded

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/12/2021
Actual
20/10/2022
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
10
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20569 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 20570 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 35352 0
6150 - Murdoch
Recruitment postcode(s) [2] 35353 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 309750 0
Hospital
Name [1] 309750 0
Fiona Stanley Hospital
Country [1] 309750 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Drive
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 310771 0
None
Name [1] 310771 0
Address [1] 310771 0
Country [1] 310771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309506 0
Southern Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 309506 0
Southern Metropolitan Health Service
14 Barry Marshall Drive
Murdoch
WA 6150
Ethics committee country [1] 309506 0
Australia
Date submitted for ethics approval [1] 309506 0
Approval date [1] 309506 0
28/11/2018
Ethics approval number [1] 309506 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114394 0
Dr Hilary Martin
Address 114394 0
Medical Oncology Department
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch WA
6150
Country 114394 0
Australia
Phone 114394 0
+61861522222
Fax 114394 0
Email 114394 0
[email protected]
Contact person for public queries
Name 114395 0
Dr Hilary Martin
Address 114395 0
Medical Oncology Department
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch WA
6150
Country 114395 0
Australia
Phone 114395 0
+61861522222
Fax 114395 0
Email 114395 0
[email protected]
Contact person for scientific queries
Name 114396 0
Dr Hilary Martin
Address 114396 0
Medical Oncology Department
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch WA
6150
Country 114396 0
Australia
Phone 114396 0
+61861522222
Fax 114396 0
Email 114396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.