None listed
Conditions
Brief summary
This study will compare the accuracy of an investigative imaging technique (known as 68Ga-CPCR4-2 (68Ga-Pentixafor) PET/CT imaging) with conventional staging (contrast enhanced Pelvic MRI and CT chest, abdomen and pelvis) at initial diagnosis of rectal 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, newly diagnosed rectal adenocarcinoma (of any subtype). Study details All participants in this study will undergo a 68Ga-CPCR4-2 (68Ga-Pentixafor) PET scan together with a contemporaneous, non contrast, low dose CT for anatomical correlation, in one session, at the Herston Imaging Research facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of 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 45 minutes. We will monitor all participants for adverse events for 30 days after the PET scan or until the time of treatment initiation whichever comes first. We will also measure the level of tracer uptake by the cancer . If results of this study are promising, we hope to further explore the impact of the PET tracer on management decisions, diagnostic accuracy, as well as the prognostic impact of the uptake of this tracer.
Interventions
As part of the clinical trail participants with biopsy proven, newly diagnosed rectal adenocarcinoma, of all clinical stages, will undergo a 68Ga-CPCR4-2 PET scan with a, non contrast, low dose CT (68Ga-CPCR4-2 PET/CT) in one session, at the Herston Imaging Research facility (HIRF).
The PET/CT scan will take approximately 45 mins.
As part of the clinical trial participants will be required to have an extra scan (68Ga-CPCR4-2 PET/CT) on top of the required standard diagnostic evaluations.
A q
As part of the clinical trail participants with biopsy proven, newly diagnosed rectal adenocarcinoma, of all clinical stages, will undergo a 68Ga-CPCR4-2 PET scan with a, non contrast, low dose CT (68Ga-CPCR4-2 PET/CT) in one session, at the Herston Imaging Research facility (HIRF). The PET/CT scan will take approximately 45 mins. As part of the clinical trial participants will be required to have an extra scan (68Ga-CPCR4-2 PET/CT) on top of the required standard diagnostic evaluations. A qualified Nuclear Medicine Technologist will administer the 68Ga-CPCR4-2 intravenously and perform the scan and a qualified Nuclear Medicine Physician will interpret the results. The clinical trial scan will be undertaken when post diagnosis, prior to surgery or any other treatment commencing.
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 1) Biopsy proven newly diagnosed rectal adenocarcinoma (of any subtype) 2) Tumour must lie within 15 cm of the anal verge and be below the peritoneal reflection. 3) Age > 18 years 4) Written informed consent 5) All women of child bearing age must have a pregnancy test before enrolment
Exclusion criteria
Exclusion Criteria 1) Rectal cancer of any other histopathology eg: neuroendocrine, small cell, squamous cell etc. 2) Any other diagnosis of cancer that the investigating team feel might complicate the interpretation of the PET findings. 3) Locally recurrent rectal cancer. 4) Unable to undergo a PET scan, in the opinion of the investigators, for any reason. 5) Pregnant or breast feeding
Outcome results
None listed