None listed
Conditions
Brief summary
What is the purpose of this clinical trial? The main goal of this study is to assess how well a new imaging agent, called 68Ga-3BP-6146, can detect solid tumour lesions in people with advanced cancer. Who is it for? You may be eligible to take part in this study if you are an adult who has been diagnosed with non-small-cell lung cancer, breast cancer, or gastrointestinal cancer (excluding neuroendocrine tumours). What does the study involve? All participants will receive a single injection of the imaging agent 68Ga-3BP-6146, which binds to a protein called uPAR that may be present on some cancer cells. Participants will then undergo PET/CT scans at 1 hour and 4 hours after the injection. Each scan will take approximately 16 minutes. You will also be monitored for any possible side effects during the imaging process and for 48 hours after the injection. [If applicable: Additional blood tests or safety assessments may be performed during this time.] What is the potential benefit? It is hoped that this study will help determine whether this new imaging agent can effectively detect tumours, which may assist in future research and clinical care.
Interventions
Non-radioactive active pharmaceutical ingredient 3BP-6146 is supplied in form of lyophilized solid to Quantum Pharma Australia Pty Ltd. Australian and local regulations for producing radiopharmaceuticals from active pharmaceutical ingredients and subsequent quality control testing apply.
A single dose of 200 MBq (+/-10%) 68Ga-3BP-6146 will be administered as an intravenous bolus injection under the supervision of the study Investigator or appropriately qualified delegate on Day 1 of the study. T
Non-radioactive active pharmaceutical ingredient 3BP-6146 is supplied in form of lyophilized solid to Quantum Pharma Australia Pty Ltd. Australian and local regulations for producing radiopharmaceuticals from active pharmaceutical ingredients and subsequent quality control testing apply. A single dose of 200 MBq (+/-10%) 68Ga-3BP-6146 will be administered as an intravenous bolus injection under the supervision of the study Investigator or appropriately qualified delegate on Day 1 of the study. The line may be flushed with 0.9% sodium chloride before and after the end of injection, per institutional guidelines. Premedications may be administered per Investigator discretion. Low dose PET/CT imaging will be done at 1 hour (+/-15 minutes) and 4 hours (+/-30 minutes) post administration of the dose. Each scan will take approximately 16 minutes to complete. Adherence and fidelity to the intervention are monitored through regular audits of nursing and medical documentation, as well as review of study data collected in source documents and CRFs. Only qualified personnel who have completed protocol-specific training are authorised to prepare and administer the investigational radiopharmaceutical. Administration procedures are supported by standardised checklists and a double-check process to ensure compliance with the protocol and maintain patient safety.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures. 2) Adult participant’s 18 years of age or older. 3) Histologically confirmed diagnosis of advanced non-small-cell lung, breast, or gastrointestinal cancer (except neuroendocrine tumours). Tumors must have progressed during or after the most recent line of anticancer therapy. 4) Signed, written informed consent.
Exclusion criteria
1) Have any medical condition that would, in the Investigator’s judgment, prevent the participant’s full participation in the clinical study due to safety concerns or compliance with clinical study procedures 2) Currently taking anticancer therapy with evidence of disease stabilization. 3) History of allergic reactions and/or known or expected hypersensitivity to peptide therapeutics, including 68Ga-3BP-6146 or any of its excipients. 4) Inadequate organ function as reflected in laboratory parameters: - Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x upper limit of normal (ULN) - Platelet count of < 75 x 109/L - Absolute neutrophil count (ANC) < 1.0 x 109/L - Haemoglobin < 8 g/dL - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x ULN, or > 5 x ULN for patients with known liver metastases - Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert’s syndrome who are eligible if total bilirubin less than or equal to 3 x ULN
Outcome results
None listed