None listed
Conditions
Brief summary
This study is looking at a new way of detecting the spread of pancreatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have biopsy proven pancreatic adenocarcinoma. The tumour may be operable, locally advanced or metastatic. Any prior treatment is allowed. Study details All participants in this study will undergo a single 68Ga-CPCR4-2 PET/CT at the Herston Imaging Research facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into your vein and inject a radioactive substance called 68Ga-Pentixafor. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid-thigh. The scan time for the 68Ga-Pentixafor PET/CT will be approximately 35 - 40 minutes. An 18F-FDGPET/CT scan will also be conducted at HIRF for patients identified to have metastatic disease at diagnosis. You will be asked to fast for 6 hours prior to the scan. A qualified Nuclear Medicine Technologist will insert a tube into your vein and inject radioactive substance called FDG. You will then be required to wait for 1 hour, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported and arms resting above your head. You will be scanned from head to mid-thigh. The scan time for the FDG-PET/CT will be approximately 30 minutes. Patients with localised pancreatic cancer at diagnosis will undergo standard of care FDG-PET/CT scan performed at the Royal Brisbane and Women’s Hospital Department of Nuclear Medicine. We will monitor all participants for adverse events. Before, during and for 30 days after your PET/CT Scans or until treatment begins you will be asked to report any side effects to your doctor. It is hoped that this study will help us to achieve more accurate staging at diagnosis to guide future treatment decisions.
Interventions
All clinical trial participants will undergo two scans as part of the clinical trial as detailed below.
All participants will receive a 68Ga-CPCR4-2 PET/CT examination on Siemens Biograph mCT Flow at Herston Imaging Research Facility (HIRF). Images will be acquired 1 hour post intravenous injection of 68Ga-CPCR4-2 (68Ga-Pentixafor) using standard activity of 150MBq. The scan range is from vertex to mid-thigh acquired using 3 minutes per bed position. Patients will be required to lie supine for
All clinical trial participants will undergo two scans as part of the clinical trial as detailed below. All participants will receive a 68Ga-CPCR4-2 PET/CT examination on Siemens Biograph mCT Flow at Herston Imaging Research Facility (HIRF). Images will be acquired 1 hour post intravenous injection of 68Ga-CPCR4-2 (68Ga-Pentixafor) using standard activity of 150MBq. The scan range is from vertex to mid-thigh acquired using 3 minutes per bed position. Patients will be required to lie supine for the duration of the procedure (up to 35-40 minutes). A low dose CT (LDCT) scan will be acquired for the purpose of attenuation correction of PET images and anatomical localisation. For subjects with metastatic pancreatic cancer, an F-18 FDG PET/CT examination will be performed on Siemens Biograph mCT Flow at HIRF. Imaging will be performed as per standard clinical protocol. Participants will be required to fast for 6 hours and F-18 FDG images will be acquired 1 hour post injection of F-18 FDG using the standard dose algorithm 4.5MBq/kg (up to a maximum 370MBq). The scan range is from vertex to mid-thigh. Patients will be required to lie supine for the duration of the procedure (up to 30 minutes). A low dose CT (LDCT) scan will be acquired for the purpose of attenuation correction of PET images and anatomical localisation. Subjects presenting with localised pancreatic cancer will undergo standard of care F-18 FDG PET/CT imaging at Royal Brisbane and Women’s Hospital Department of Nuclear Medicine. Participants with Metastatic Pancreatic Cancer will undergo a F-18 FDG PET at HIRF because those diagnosed with Metastatic Pancreatic Cancer do not normally undergo a F-18 FDG PET as part of standard of care diagnosis imaging. The FDG PET scan at HIRF for metastatic patients will proceed regardless of the results from the first scan. 68Ga-CPCR4-2 and F-18 FDG imaging will be performed on different days but will be completed within a week of each other. A qualified Nuclear Medicine Technologist will administer both the 68Ga-CPCR4-2 and F-18 FDG Tracer to participants and perform the scan. Interpretation of the results of the PET/CT scans will be performed by a qualified Nuclear Medicine Physician.
Sponsors
Royal Brisbane and Women'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
Inclusion Criteria a) Biopsy proven pancreatic adenocarcinoma. The tumour may be operable, locally advanced or metastatic. Any prior treatment is allowed. b) Age 18 years and over c) Written informed consent d) All women of child bearing age must have a pregnancy test before enrolment
Exclusion criteria
Exclusion Criteria a) Any pancreatic tumours other than adenocarcinoma. For example, mucinous neoplasms, adenomas, neuroendocrine tumours or other malignancies metastasizing to the pancreas will all be excluded. b) Patients with tumours of the ampulla or biliary tree c) Patients unable to undergo a PET scan for any reason, in the opinion of the investigator. d) Pregnant or breastfeeding
Outcome results
None listed