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Trial registered on ANZCTR


Registration number
ACTRN12617000592347
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
27/04/2017
Date last updated
27/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
CXCR4 PET/CT for Head and Neck Squamous Cell Carcinoma (HNSCC) staging.
Scientific title
A Pilot Study of CXCR4 PET for nodal staging of resectable mucosal head and neck Squamous cell carcinoma (HNSCC), including correlation with histopathology immunohistochemistry, sputum and Circulating Tumour Cells.
Secondary ID [1] 291669 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 302827 0
Condition category
Condition code
Cancer 302321 302321 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297756 0
Diagnosis / Prognosis
Comparator / control treatment
Participants will receive standard of care diagnostic scanning as per the Head and Neck Multidisciplinary Team requirements.
FDG-PET Scan will act as the comparator as this is the current Standard of Care in this population.

A qualified nuclear medicine technologist will be responsible of administering the tracers and performing the scans and a qualified nuclear medicine physician will interpret the results.
Control group
Active

Outcomes
Primary outcome [1] 301730 0
CXCR4 receptor expression in Oral cavity SCC and other head and neck mucosal subsites (eg larynx and hypopharynx) assessed by FDG PET/CT scan.
Timepoint [1] 301730 0
Diagnosis
Secondary outcome [1] 333696 0
CXCR4 receptor expression in Oral cavity SCC and other head and neck mucosal subsites (eg larynx and hypopharynx) assessed by PET MRI.
Timepoint [1] 333696 0
Diagnosis
Secondary outcome [2] 333900 0
Utilise measurements of salivary miRNA expression levels.
Timepoint [2] 333900 0
Diagnosis
Secondary outcome [3] 333901 0
Feasibility of performing simultaneous PET/MR, assessed by proportion of enrolled participants completing the protocol, and by semi-structured interviews with treating clinicians.
Timepoint [3] 333901 0
Diagnosis
Secondary outcome [4] 333902 0
The relationship between tumoural CXCR4 expression and established novel markers of immune cell infiltration and function will be assessed as an exploratory endpoint.

Tests relating to exploratory endpoints of immune correlates of CXCR4 expression will be performed primarily at QIMR Berghofer:
* Flow cytometry will be performed on fresh tumour tissue to quantify protein expression indicating presence of
* Immune cell subsets of interest including T cells (TCRBeta/CD3), T cell subsets (CD4/8, FoxP3), NK cells (CD56 and others), others (e.g. CD11b)
* Immune modifiers (which may include T-cell immune checkpoints and other markers such as PD-1/PD-L1, CTLA-4, TIGIT, CD96/CD155) and markers of function (which may include IFN, IL-2, Granzyme B and others)
* CXCR4 expression on tumour-infiltrating immune cells and tumour/stroma tissue
* Standard assays of immune cell function employing in-vitro techniques such as mixed lymphocyte reaction, T cell stimulation, treatment with monoclonal antibodies

All immunological studies are being performed in the lab of Prof Mark Smyth (Team Head, Immunology in Cancer and Infection, QIMRB), and may be shared with scientific collaborators after HREC review. These results are not relevant to the treatment of the patient and do not need to be communicated with the treatment physicians.
Timepoint [4] 333902 0
Diagnosis
Secondary outcome [5] 334004 0
Circulating tumour cell levels, assessed by serum assay.
Timepoint [5] 334004 0
Diagnosis

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296168 0
Hospital
Name [1] 296168 0
Herston Imaging Research Facility Seed Funding
Country [1] 296168 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 295072 0
None
Name [1] 295072 0
Address [1] 295072 0
Country [1] 295072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297413 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 297413 0
Ethics committee country [1] 297413 0
Australia
Date submitted for ethics approval [1] 297413 0
28/11/2016
Approval date [1] 297413 0
23/12/2016
Ethics approval number [1] 297413 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73962 0
Prof Lizbeth Kenny
Address 73962 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73962 0
Australia
Phone 73962 0
+61 7 3646 8111
Fax 73962 0
Email 73962 0
lizbeth.kenny@health.qld.gov.au
Contact person for public queries
Name 73963 0
Jacqui Keller
Address 73963 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73963 0
Australia
Phone 73963 0
+61 7 3646 8111
Fax 73963 0
Email 73963 0
jacqui.keller@health.qld.gov.au
Contact person for scientific queries
Name 73964 0
Lizbeth Kenny
Address 73964 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73964 0
Australia
Phone 73964 0
+61 7 3646 8111
Fax 73964 0
Email 73964 0
lizbeth.kenny@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.