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)

St Vincent's Hospital0 个研究点目标入组 7 人开始时间: 2019年10月10日最近更新: 2021年12月21日

适应症

试验速览

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•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)

•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

发起方

St Vincent's Hospital