None listed
Conditions
Brief summary
This study aims to evaluate the impact of a novel positron emission tomography tracer, called Gallium 68-Fibroblast Activation Protein Inhibitor-04 Positron Emission Tomography/ Computed Tomography ( [68Ga]Ga-FAPI-04 PET/CT or FAPI PET/CT) on initial staging of breast cancer patients. Who is it for? You may be eligible for this study if you are an adult patient who has been diagnosed with locally advanced and/or node positive, high risk (stage 2B to 3C) Invasive Lobular Breast cancer (ILC). Study details Participants will receive an injection of a radioactive tracer agent (FAPI-04) before undergoing 15-20 minute PET/CT scan. Participants and their treating clinicians will be followed up for information on their disease stage and clinical management over 12 months post-scan. It is hoped that findings from this study help doctors and researchers understand the clinical utility and impact of FAPI PET/CT in the staging and management of Invasive Lobular Breast Cancer.
Interventions
Intervention Name: [68Ga] (Gallium)]-Fibroblast activation Protein inhibitor (FAPI)-04 PET/CT Imaging Procedure
Short Intervention name: [68Ga]Ga-FAPI-04 PET/CT (FAPI PET/CT). A weight based dose of [68Ga]Ga-FAPI-04 tracer dose will be injected intravenously. After a 30 minute resting (uptake) time the patient will be scanned on a digital PET/CT scanner (United Imaging uMI 780), Total scan time will be approximately 15 - 20 minutes (depending on patient height). Total appointment time for the s
Intervention Name: [68Ga] (Gallium)]-Fibroblast activation Protein inhibitor (FAPI)-04 PET/CT Imaging Procedure Short Intervention name: [68Ga]Ga-FAPI-04 PET/CT (FAPI PET/CT). A weight based dose of [68Ga]Ga-FAPI-04 tracer dose will be injected intravenously. After a 30 minute resting (uptake) time the patient will be scanned on a digital PET/CT scanner (United Imaging uMI 780), Total scan time will be approximately 15 - 20 minutes (depending on patient height). Total appointment time for the scan including preparation before the scan will be 90 minutes. A Data Safety and Monitoring Committee (DSMC) has been established, comprising of 2 external Oncologists, independent Biostatistician and Mercy Molecular Imaging and Therapy Operations manager (who is not directly involved in study). DSMC will be responsible for monitoring of adherence to the intervention. A 6 monthly report will be provided to DSMC. A Single intervention of FAPI PET/CT Imaging will be performed onsite for each trial participant and delivered by qualified members of our research team, including Nuclear Medicine Imaging Technicians and Radio Pharmacist, Radiologist, Research Nurse.
Sponsors
Mercy Radiology, Epsom, Auckland
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
Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1. Histologically proven invasive lobular breast cancer with stage 2B to 3C based on conventional pathological and radiological staging currently available in New Zealand and based on local practice. 2. Participant must be 18 years of age and over, at the time of signing the informed consent. 3. Participants must be able to give consent to the study and understand the study information. 4. Participants who have newly diagnosed ILC without known distant metastatic disease on conventional imaging. 5. Capable of giving signed informed consent as described including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Exclusion criteria
Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. Participants with a history of other known malignancy 2. Impaired renal function of eGFR <30 3. Unable to give consent 4. Known hypersensitivity to CT contrast (Omnipaque) 5. Participants who return a positive pregnancy test at Day 0.
Outcome results
None listed