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Trial registered on ANZCTR


Registration number
ACTRN12624000918527p
Ethics application status
Not yet submitted
Date submitted
1/07/2024
Date registered
29/07/2024
Date last updated
29/07/2024
Date data sharing statement initially provided
29/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Fluorodeoxyglucose (FDG) and human epidermal growth factor receptor 2 (HER2) positron emission tomography (PET) scan in breast cancer
Scientific title
Appraising the utility of whole tumour heterogeneity assessment by novel HER2 PET scanning compared to standard-of-care FDG-PET scanning in metastatic breast cancer
Secondary ID [1] 312403 0
2024/GR000912
Universal Trial Number (UTN)
U1111-1309-8481
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 334213 0
Condition category
Condition code
Cancer 330878 330878 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to fast for a few hours before the FDG- and HER2-PET scans. If participants are diabetic, they will be given instructions about their diabetes medications and their blood sugar will be checked upon arrival at the hospital.

Participants will be asked to undergo a standard-of-care FDG-PET scan and a novel HER2-PET scan at baseline in the Nuclear Medicine Department at Fiona Stanley Hospital. Each scan will occur on different days within 1 week. We will ask participants to wait a minimum of 24 hours between scans. It is expected that the entire procedure will take 2-3 hours per scan. The entire procedure will be conducted by Radiologists and Nuclear Medicine physician's and their team.

The Australian Diagnostic Reference Level (DRL) for standard FDG-PET imaging is 3.5 MBq/kg (for patients weighing between 50 and 120 kg). The 68Gallium-HER tracer will be administered at a dose of 107MBq.

As participants will have HER2 positive or HER2 low metastatic breast cancer, baseline will be prior to treatment with the antibody-drug conjugate trastuzumab-deruxtecan (T-Dxd).

The HER2-PET scan uses gallium-labelled HER2 binding peptides that have an affinity for the HER2 receptors which are present in many breast cancers. The radio-isotope injection (HER2 or FDG) is administered via a needle (cannula) into a vein in the hand or arm. Following this, participants will undergo positron emission tomography (PET). This involves participants entering a PET scanner for approximately 20 minutes.

Upon disease progression based on RECIST criteria, participants will be asked to undergo a second FDG-PET and HER2-PET scan. After these second scans, this will be the end of the study for participants with progressive disease. Treating clinicians will determine further monitoring appropriate for each individual.

Participants with stable disease throughout the study will return to standard follow-up imaging as determined by the treating clinician and this will be the end of the study.

For those with HER2 avid but FDG-PET non-avid disease with known visceral disease, CT scan will also be performed

It is anticipated that the study will take 1 year from the date of recruitment.

As this is a PET scan study, there is no requirement for adherence to an intervention. However, we will monitor scan attendance and record results in electronic medical records.
Intervention code [1] 328908 0
Diagnosis / Prognosis
Comparator / control treatment
Controlled. The novel HER2-PET scan will be compared to the standard-of-care FDG-PET scan, and as such the FDG-PET scan constitutes the comparator/control treatment in this study.
Control group
Active

Outcomes
Primary outcome [1] 338633 0
Feasibility of HER2-PET scanning.
Timepoint [1] 338633 0
At time of first study scan.
Primary outcome [2] 338799 0
Quantitative assessment of the clinical accuracy of each imaging modality.
Timepoint [2] 338799 0
At time of first study scan and any additional scans completed upon disease progression for 5 years post-enrolment.
Secondary outcome [1] 436746 0
Disease activity detected on HER2-PET.
Timepoint [1] 436746 0
At time of first study scan and any additional scans completed upon disease progression for 5 years post-enrolment.
Secondary outcome [2] 437509 0
Clinical assessment of treatment response.
Timepoint [2] 437509 0
At time of first study scan and any additional scans completed upon disease progression for 5 years post-enrolment.

Eligibility
Key inclusion criteria
HER2 positive or HER2 low metastatic breast cancer patient as defined by immunohistochemistry (IHC) measuring cell membrane HER2 protein and/or by in situ hybridisation (ISH) measuring the number of HER2 genes in each cell nucleus. HER2 positivity is defined as either strong (3+) cell membrane staining by IHC or amplification of the HER2 gene by ISH. Participants must be T-Dxd treatment naïve in the metastatic setting. The number of HER2 positive and HER2 low participants included in the study will be capped at five each (e.g. 5 HER2 positive and 5 HER2 low).
Minimum age
18 Years
Maximum age
No limit
Sex
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 of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Efficacy parameters are 1) sensitivity, 2) specificity, 3) positive predictive value, and 4) negative predictive value.

Methods will be compared on a per-lesion and per-patient basis.

Pearson’s Chi-square test will be used to analyse categorical variables.

Continuous data will be expressed either as the mean with standard deviation (SD) of SUVmax or as the median with interquartile range (IQR) of SUVmax, as appropriate. The percentage coefficient of variation (COV) will be calculated as the SD divided by the mean and multiplied by 100.

The difference in qualitative scores between FDG and HER2-PET images or any other matched continuous variables will be evaluated using the Wilcoxon signed-rank test. Other continuous variables will be assessed using the relevant t-test. HER2-PET will be determined to be suggestive to have clinical utility if appearing superior to FDG-PET in >=20% of patients.

The correlation of SUVmax and HER2 scores will be calculated using Spearman’s rank.

All statistical tests will be two-sided with a significance level of p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/01/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
8/02/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26730 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42777 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 316811 0
Hospital
Name [1] 316811 0
Fiona Stanley Hospital
Country [1] 316811 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
Country
Australia
Secondary sponsor category [1] 319041 0
None
Name [1] 319041 0
Address [1] 319041 0
Country [1] 319041 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315581 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315581 0
Ethics committee country [1] 315581 0
Australia
Date submitted for ethics approval [1] 315581 0
15/08/2024
Approval date [1] 315581 0
Ethics approval number [1] 315581 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135146 0
Dr Zeyad Al-Ogaili
Address 135146 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, Western Australia 6150
Country 135146 0
Australia
Phone 135146 0
+61 8 61525067
Fax 135146 0
Email 135146 0
zeyad.al-ogaili@health.wa.gov.au
Contact person for public queries
Name 135147 0
Katie Meehan
Address 135147 0
Harry Perkins Insistute of Medical Research (South), 5 Robin Warren Dr, Murdoch WA 6150
Country 135147 0
Australia
Phone 135147 0
+61 8 6151 1141
Fax 135147 0
Email 135147 0
katie.meehan@uwa.edu.au
Contact person for scientific queries
Name 135148 0
Andrew Redfern
Address 135148 0
Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, Western Australia 6150
Country 135148 0
Australia
Phone 135148 0
+61 8 6151 1141
Fax 135148 0
Email 135148 0
andrew.redfern@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified participant data to be shared includes all individual participant data collected during the trial.
When will data be available (start and end dates)?
Start date: June 2027
End date: July 2028
Available to whom?
Clinical trial consented participants that have adhered to all inclusion and exclusion criteria. This is subject to approval by Principal Investigator Dr Al-Ogaili, Zeyad and institutional human ethics approval.
EMAIL: Zeyad.Al-Ogaili@health.wa.gov.au
Available for what types of analyses?
Any protocol approved by the principal investigator and contingent on appropriate institutional ethics approvals.
How or where can data be obtained?
By email from the principal investigator Dr Al-Ogaili, Zeyad.
EMAIL: Zeyad.Al-Ogaili@health.wa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23988Study protocol    388022-(Uploaded-12-07-2024-18-18-05)-HER2-PET Protocol v1 18 June 2024.doc



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.