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Trial registered on ANZCTR


Registration number
ACTRN12619001383156
Ethics application status
Approved
Date submitted
6/09/2019
Date registered
10/10/2019
Date last updated
15/12/2021
Date data sharing statement initially provided
10/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial assessment of the diagnostic value of Cu64 SAR-Bombesin PET/CT imaging for staging of ER/PR + HER2- breast cancer patients with metastatic disease in comparison with conventional imaging (CT, bone scan and 18F-FDG PET/CT)
Scientific title
Pilot trial assessment of the diagnostic value of Cu64 SAR-Bombesin PET/CT imaging for staging of ER/PR + HER2- breast cancer patients with metastatic disease in comparison with conventional imaging (CT, bone scan and 18F-FDG PET/CT)
Secondary ID [1] 299202 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone Positive Metastatic Breast Cancer 314308 0
Condition category
Condition code
Cancer 312658 312658 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient will be given an appointment to come to the St Vincent's Hospital Sydney Department of Theranostics and Nuclear Medicine Department.

Pre-intervention checks (i.e. baseline blood tests, baseline vitals, and 12 lead ECG) will be conducted on presentation to the department.

The intervention will firstly involve a once-off injection of 64Cu-Bombesin radiotracer (Dose 200 MBq +/- 10%) which will be administered by accredited Nuclear Medicine Technologists in the St Vincent's Hospital Theranostics and Nuclear Medicine Department. A PET scan will then be performed 1-hour after the injection and will take approximately 25 minutes to complete. Fidelity to the intervention will be monitored using usual departmental processes (i.e. two-person time-out checks, departmental audits, etc.)

Whole Blood 64Cu SAR BBN radiation assay will then be taken at 1-hour, 3-hours, and 24-hours post-injection, which will be processed by Clarity Pharmaceuticals.
Intervention code [1] 315496 0
Diagnosis / Prognosis
Comparator / control treatment
All participants will receive conventional Imaging (i.e. all participants will have a CT, bone scan, 18F-FDG PET/CT). These will be performed approximately 2-weeks prior to the 64Cu-Bombesin PET scan.

Bone scan will take approximately 3-hours, and CT and 18F-FDG PET will be performed together and take approximately 2-hours. Scans will be administered by Nuclear Medicine Technicians
Control group
Active

Outcomes
Primary outcome [1] 321310 0
To explore the diagnostic accuracy of 64Cu SAR Bombesin PET CT compared to conventional re-staging imaging in patients with biopsy proven metastatic ER/PR+ breast cancer.

Diagnostic accuracy will be assessed by comparing to lesions found on conventional imaging, and if new lesions are found on 64Cu-Bombesin PET, patients will be given an option for biopsy by their Oncologist to investigate further (purely voluntary).

Conventional imaging includes CT, bone scan, and 18F-FDG PET/CT
Timepoint [1] 321310 0
Upon participant completing all imaging studies
Primary outcome [2] 321311 0
To compare the diagnostic/quantitative parameters of 64Cu- Bombesin imaging to FDG PET CT in patients with metastatic ER/PR+ HER2- breast cancer undergoing staging imaging for clinical purposes (composite primary outcome)
- Diagnostic/quantitative outcomes will be assessed by comparing 64Cu-Bombesin imaging findings compared to conventional FDG PET CT findings

Diagnostic/quantitative parameters will be assessed by comparing detection of lesions found (if any) using 64Cu-Bombesin PET and FDG PET imaging, and assessing degree of uptake of any lesions identified using SUV Max/Mean
Timepoint [2] 321311 0
Upon participant completing both 64Cu-Bombesin imaging and FDG PET CT
Primary outcome [3] 321312 0
To perform radiation dosimetry of 64Cu Bombesin
- Outcome is to assess radiation dose of 64Cu Bombesin to assess its theranostics potential

Theranostic potential will be assessed by using analaysis of Whole Blood 64Cu SAR BBN radiation assay.
Timepoint [3] 321312 0
1-hour, 3-hours, and 4-hours post-injection of 64Cu Bombesin by way of Whole Blood 64Cu SAR BBN radiation assay
Secondary outcome [1] 375362 0
To compare 64Cu SAR BBN PET CT and FDG PET CT imaging results to histopathological characteristics of individual patients/tumours (ER/PR status/Ki 67/gastrin releasing peptide receptor staining/SBR grade).

NB: this is a composite secondary outcome that will be assessed by correlating both 64Cu SAR BBN PET and FDG PET results (i.e. lesion size, location, radiotracer uptake), and correlating these imaging findings with the known histopathology of the individual patient's breast cancer (i.e. hormone profile).

The hormone profile of the breast cancer will include ER/PR status/Ki 67/gastrin releasing peptide receptor staining/SBR grade.

Outcome assessed will be to determine if there is any correlation between hormonal profile and 64Cu-Bombesin PET imaging findings
Timepoint [1] 375362 0
Upon participant completing both 64CU-Bombesin imaging and FDG PET CT

Eligibility
Key inclusion criteria
Ability to provide informed consent documentation indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study
Female patients aged 18 or above with ER/PR +ve metastatic breast cancer being restaged prior to treatment of metastatic disease.
Have a 12 lead ECG recording on their first visit showing the following,
Heart rate between 45 and 100 beats per minute
Corrected QT interval of less than or equal to 450ms
No clinically significant abnormalities including morphology (Eg, left bundle branch block, atrioventricular nodal dysfunction, ST segment abnormalities)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or lactation
Significant inter-current acute illness including (but not limited to) requiring the use of intravenous antibiotics, illness associated with any signs of haemodynamic instability, or illness as determined by trial investigators that warrant other emergent treatment
ECOG status higher than 2
History of significant renal (CKD grade 2 or above) or hepatic disease (MELD score of 1 or above)
Major surgery (any procedure requiring general anaesthesia) in 6 weeks prior to visit 1
Use of immunosuppresants or known immunosuppressed state
History of cancers other than breast cancer
Clinically significant abnormal values for safety laboratory tests (haematology, biochemistry or urinalysis) or vital signs at visit 1
Any other reason that the investigator considers makes the patient unsuitable to participate

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/11/2019
Actual
28/07/2020
Date of last participant enrolment
Anticipated
Actual
29/06/2021
Date of last data collection
Anticipated
Actual
29/06/2021
Sample size
Target
10
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14740 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 27782 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 303741 0
Hospital
Name [1] 303741 0
St Vincent's Hospital
Country [1] 303741 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
390 Victoria Street Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 303860 0
None
Name [1] 303860 0
Address [1] 303860 0
Country [1] 303860 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304266 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 304266 0
Ethics committee country [1] 304266 0
Australia
Date submitted for ethics approval [1] 304266 0
09/09/2019
Approval date [1] 304266 0
04/10/2019
Ethics approval number [1] 304266 0

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

Contacts
Principal investigator
Name 96342 0
A/Prof Louise Emmett
Address 96342 0
St Vincent's Hospital
Department of Nuclear Medicine and Theranostics
390 Victoria Street
Darlinghurst NSW 2010
Country 96342 0
Australia
Phone 96342 0
+61 2 83821111
Fax 96342 0
Email 96342 0
Louise.Emmett@svha.org.au
Contact person for public queries
Name 96343 0
Louise Emmett
Address 96343 0
St Vincent's Hospital
Department of Nuclear Medicine and Theranostics
390 Victoria Street
Darlinghurst NSW 2010
Country 96343 0
Australia
Phone 96343 0
+61 2 83821111
Fax 96343 0
Email 96343 0
Louise.Emmett@svha.org.au
Contact person for scientific queries
Name 96344 0
Louise Emmett
Address 96344 0
St Vincent's Hospital
Department of Nuclear Medicine and Theranostics
390 Victoria Street
Darlinghurst NSW 2010
Country 96344 0
Australia
Phone 96344 0
+61 2 83821111
Fax 96344 0
Email 96344 0
Louise.Emmett@svha.org.au

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


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
SourceTitleYear of PublicationDOI
Embase64Cu-SAR-Bombesin PET-CT Imaging in the Staging of Estrogen/Progesterone Receptor Positive, HER2 Negative Metastatic Breast Cancer Patients: Safety, Dosimetry and Feasibility in a Phase I Trial.2022https://dx.doi.org/10.3390/ph15070772
Dimensions AICopper-67-Labeled Bombesin Peptide for Targeted Radionuclide Therapy of Prostate Cancer2022https://doi.org/10.3390/ph15060728
N.B. These documents automatically identified may not have been verified by the study sponsor.