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Trial registered on ANZCTR


Trial ID
ACTRN12617000595314
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
A study to look at a new way of detecting the spread of pancreas cancer.
Scientific title
A study to evaluate the sensitivity and specificity of imaging the CXCR4 Chemokine receptor with a novel PET tracer in pancreatic cance
Secondary ID [1] 291672 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Adenocarcinoma 302830 0
Condition category
Condition code
Cancer 302324 302324 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297760 0
Diagnosis / Prognosis
Comparator / control treatment
In this pilot study, we wish to gain preliminary information on the sensitivity and specificity of 68Ga-CPCR4-2 PET in pancreatic adenocarcinomas. To do this the clinical trial will compare the uptake seen of primary pancreatic tumours, metastases, and other extra-pancreatic lesions on 68Ga-CPCR4-2 PET/CT with the findings on standard imaging studies, FDG-PET/CT.

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.
Control group
Active

Outcomes
Primary outcome [1] 301734 0
Sensitivity and specificity of 68Ga-CPCR4-2 PET in detecting the spread of pancreatic adenocarcinomas, assessed by comparison to standard imaging studies, FDG-PET/CT.
Timepoint [1] 301734 0
Following completion of standard imaging.
Secondary outcome [1] 333700 0
a) To measure the uptake of the 68Ga-CPCR4-2 PET/CT tracer, (measured by SUV) in primary pancreatic adenocarcinomas and metastases


Timepoint [1] 333700 0
At time of 68Ga-CPCR4-2 PET/CT tracer scan.
Secondary outcome [2] 333895 0
Compare the uptake seen of primary pancreatic tumours, metastases, and other extra-pancreatic lesions on 68Ga-CPCR4-2 PET/CT with the findings on standard imaging studies, including FDG-PET/CT.
Uptake will be assessed using the current programs and assessment tools used within the Nuclear Medicine such as SUV.
Timepoint [2] 333895 0
Following completion of standard imaging.
Secondary outcome [3] 333896 0
c) Monitor adverse events of participants receiving 68Ga-CPCR4-2 PET/CT.

The PET/CT and PET/MRI procedure:
Common risks and complications include:
1. Minor pain and bruising
Less common risks and complications include:
1. Infection from an intravenous cannula site that may require treatment with antibiotics
2. An allergy to injected drugs may occur, requiring further treatment
Rare risks and complications include:
1. Death as a result of this procedure is very rare

All adverse events reported by the subject/or in response to questioning or observation by the Principal Investigator will be recorded from the time of consent, during the imaging sessions and for 30 days after the PET scan or until the time of treatment initiation whichever comes first.
Timepoint [3] 333896 0
At time of 68Ga-CPCR4-2 PET/CT tracer scan and until 30 days post scan or until treatment initiation whichever comes first.

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

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296171 0
Hospital
Name [1] 296171 0
Royal Brisbane and Women's Hospital Herston Imaging Research Facility Seed Funding
Address [1] 296171 0
Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country [1] 296171 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] 295075 0
None
Name [1] 295075 0
Address [1] 295075 0
Country [1] 295075 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297416 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 297416 0
Level 7 Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 297416 0
Australia
Date submitted for ethics approval [1] 297416 0
31/10/2016
Approval date [1] 297416 0
23/12/2016
Ethics approval number [1] 297416 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73974 0
Dr Matthew Burge
Address 73974 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73974 0
Australia
Phone 73974 0
+61 7 3646 8111
Fax 73974 0
Email 73974 0
matthew.burge@health.qld.gov.au
Contact person for public queries
Name 73975 0
Ms Annette Cubitt
Address 73975 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73975 0
Australia
Phone 73975 0
+61 7 3646 8111
Fax 73975 0
Email 73975 0
annette.cubitt@health.qld.gov.au
Contact person for scientific queries
Name 73976 0
Dr Matthew Burge
Address 73976 0
Cancer Care Services
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Country 73976 0
Australia
Phone 73976 0
+61 7 3646 8111
Fax 73976 0
Email 73976 0
matthew.burge@health.qld.gov.au