None listed
Conditions
Brief summary
This study aims to evaluate the use of an investigative imaging technique, known as CXCR4 positron emission tomography (PET), for disease staging in patients with resectable mucosal head and neck squamous cell carcinoma (HNSCC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have biopsy proven mucosal head and neck SCC suitable for upfront surgery with planned neck dissection. Study details Prior to resection and in addition to our usual standard of care assessments, all participants in this study will be imaged with PET/CT and PET/MRI with a CXCR4 tracer (68Ga-CPCR4-2) and have blood and saliva collected.
Interventions
The study intervention is the addition of PET/MR, a PET/CT image using a CXCR4 tracer (68Ga-CPCR4-2) and an additional FDG PET/CT scan. We would also take saliva and blood samples. The scans and samples will be taken within 36 hours of each-other and be at least 4.5 hours apart. It is standard for biopsy samples to be taken during surgery, but in addition their location would be recorded. Tissue will be obtained from the surgical procedure. There will be no impact on usual patient care. Partici
The study intervention is the addition of PET/MR, a PET/CT image using a CXCR4 tracer (68Ga-CPCR4-2) and an additional FDG PET/CT scan. We would also take saliva and blood samples. The scans and samples will be taken within 36 hours of each-other and be at least 4.5 hours apart. It is standard for biopsy samples to be taken during surgery, but in addition their location would be recorded. Tissue will be obtained from the surgical procedure. There will be no impact on usual patient care. Participants will also receive MR contrast agent so as to obtain a standard of care MRI acquisition during the PET/MR scan; in some cases, where participants have had a prior MRI scan, the use of MR contrast agent will be an additional intervention. Blood samples Before imaging begins, a blood sample will be taken by injecting a needle into a vein and letting a small amount of blood pool into a collection tube. Three tubes of blood will be taken but from the same needle. Session 1a: 68Ga-Pentixafor -PET/MR After emptying your bladder, a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called 68Ga-Pentixafor as well as MRI Contrast. The scan involves lying flat with knees supported and arms resting by your side. Only your head/neck will be scanned. The scan time for the PET/CT will be approximately 70 minutes. During this time the MR part of the scanner will make buzzing or knocking noises as it generates different kinds of images. Session 1b: 68Ga-Pentixafor-PET/CT You will be asked empty your bladder again and walk to the PET/CT scanner in the room next door. After lying down you will be scanned from head to mid-chest. This scan will last approximately 20 minutes. After the first imaging session and having a drink of water and something to eat, you will be asked to not eat or drink anything but water (drinking water is encouraged) for the four hours prior to the next scan. Saliva samples Approximately one hour after eating and drinking you will be asked to provide three saliva samples. The three saliva samples will take some time to obtain because a different method will be used each time: 1. Once after waiting for saliva to build up in the mouth, 2. Once after having had a lemon sweet, and 3. Once after rinsing with mouthwash. After the saliva samples have been taken, you will then be asked to continue to avoid eating, but encouraged to drink water. Session 2: FDG-PET/CT Four hours after eating, a qualified Nuclear Medicine Technologist will ask you empty your bladder and to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called FDG. The scan involves lying flat with knees supported and arms resting by your sides. For approximately the first 60 minutes only your head will be scanned. In the second part of the scan, you will be scanned from head to mid-chest. This will take approximately another 15 minutes. After the examination is completed, you will be able to eat and drink normally. Scanning sessions can be performed on two separate days if required but both scanning sessions need to be performed within 36 hours of the first scan starting. A nuclear medicine physician will for interpreting the results.
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 mucosal head and neck SCC suitable for upfront surgery with planned neck dissection. 2. Age 18 years and over. 3. Written informed consent 4. All women of childbearing age must have a pregnancy test before enrolment
Exclusion criteria
Exclusion Criteria 1. Patients with head and neck cancers other than SCC 2. Patients unable to undergo a PET scan for any reason, in the opinion of the investigator. 3. Patients allergic to FDG 4. Pregnant or breastfeeding 5. Diabetic 6. Prior exposure to a CTLA-4 inhibitor (e.g. ipilimumab, tremelimumab), PD-1 inhibitor (e.g. nivolumab, pembrolizumab), PD-L1 inhibitor (e.g. MEDI-4736), PD-L2 inhibitor or any or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways. 7. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study commencement. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 8. Standard MRI exclusion criteria and claustrophobia 9. Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.
Outcome results
None listed