None listed
Conditions
Brief summary
The purpose of this study is to determine the safety and diagnostic value of 64Cu-Bombesin in PET/CT imaging in patients with progressive metastatic hormone positive (oestrogen/progesterone receptor positive) breast cancer. Who is it for? You may be eligible for this study if you are a female aged 18 or above with oestrogen/progesterone receptor positive metastatic breast cancer. Study details: Participants will undergo a variety of scans over the two study visits. There will be four types of imaging: a Cu64 Bombesin PET scan in addition to conventional imaging in the form of a bone scan, CT scan, 18-FDG PET scan. Prior to the injection of Cu64 Bombesin, patients will be subject to review of their haematological and coagulation assay, ECG and vitals. The patient’s vitals will be monitored before, during and after the scan. Where the scan reveals lesions amenable to biopsy, patients may optionally be recruited for this, and consent for this obtained separately. This will allow for further characterisation of receptors present on tissue samples. The outcome of this study will potentially have important implications for the staging of hormone positive metastatic breast cancer.
Interventions
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 Th
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.
Sponsors
St Vincent's Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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)
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
Outcome results
None listed