Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000695707
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
13/05/2022
Date last updated
16/06/2023
Date data sharing statement initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Gallium-68 fibroblast activation protein inhibitor (68Ga-FAPI) positron emission tomography/computed tomography (PET/CT) versus 18F-fluorodeoxyglucose (18F-FDG) PET/CT for pancreatic cancer: A feasibility study
Scientific title
Gallium-68 fibroblast activation protein inhibitor (68Ga-FAPI) positron emission tomography/computed tomography (PET/CT) versus 18F-fluorodeoxyglucose (18F-FDG) PET/CT for pancreatic cancer: A feasibility study
Secondary ID [1] 306898 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 325996 0
Condition category
Condition code
Cancer 323308 323308 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, non-randomised, non-blinded feasibility study comparing two PET/CT tracers. This study will involve ten patients, who will each undergo both a FDG PET/CT scan and a FAPI PET/CT scan. The patients will each have a diagnosis of a pancreatic cancer and be undergoing PET/CT imaging for staging/restaging for the purposes of being considered for surgical resection. Patients in this scenario would routinely undergo a FDG PET/CT scan for the purposes of staging/restaging, thus participation in this study requires one intervention outside of standard care (the FAPI PET/CT scan).

A FDG PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital, and reported by one of the nuclear medicine radiologists involved in this study, as standard care. The approximate duration required for completion of each FDG scan is 2hrs. 2.5MBq/kg +75 of FDG tracer will be administered to each patient through intravenous cannulation. FDG tracer will be administered 60minutes prior to the PET/CT scan.

Within 1-7 days of the FDG PET/CT scan, a FAPI PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital, and reported by the same nuclear medicine radiologist. The approximate duration required for completion of each FAPI scan is 2hrs. 2.5MBq/kg of FAPI tracer will be administered to each patient through intravenous cannulation. FAPI tracer will be administered 60minutes prior to the PET/CT scan.

Doses are measured in a dose calibrator and documented on patient paperwork and the administration system. The dose calibrator is quality tested daily. The dose will be administered following a flush of 10mls of saline to test the patency of the cannula & followed by 20mls of saline to ensure the dose has gone through. Pre- and post-measurements of syringes will be made.

Once each PET/CT scan has been individually assessed, the nuclear medicine radiologist who has reported the scans will directly compare the two scans. The reporting radiologist and the patient’s Hepato-Pancreato-Biliary (HPB) surgeon will discuss the results of the PET/CT scans. Patients will continue under the care of their HPB surgeon and treating medical team, with no further study involvement.
Intervention code [1] 323348 0
Diagnosis / Prognosis
Comparator / control treatment
FAPI PET/CT scans will be compared to standard-care imaging (i.e. FDG PET/CT scans).

Control group
Active

Outcomes
Primary outcome [1] 331041 0
Feasibility of using 68Ga-FAPI-46 PET/CT for staging/restaging of pancreatic cancer, assessed by determining the number of lesions identified through FAPI PET/CT compared to FDG PET/CT.
Timepoint [1] 331041 0
Once each patient has undergone both FDG and FAPI PET/CT scans, the nuclear medicine radiologist who has reported the scans will directly compare the two scans.
Primary outcome [2] 331042 0
Feasibility of using 68Ga-FAPI-46 PET/CT for staging/restaging of pancreatic cancer, assessed by determining the difference in the tumour uptake (SUVmax) between FAPI PET/CT and FDG PET/CT.
Timepoint [2] 331042 0
Once each patient has undergone both FDG and FAPI PET/CT scans, the nuclear medicine radiologist who has reported the scans will directly compare the two scans.
Primary outcome [3] 331044 0
Feasibility of using 68Ga-FAPI-46 PET/CT for staging/restaging of pancreatic cancer, assessed by determining the difference in the background uptake (background:tumour ratio) between FAPI PET/CT and FDG PET/CT.
Timepoint [3] 331044 0
Once each patient has undergone both FDG and FAPI PET/CT scans, the nuclear medicine radiologist who has reported the scans will directly compare the two scans.
Secondary outcome [1] 408575 0
Diagnostic accuracy of 68Ga-FAPI-46 PET/CT in staging/restaging pancreatic cancer compared to FDG PET/CT. This is a composite outcome, determined by the overall results obtained by comparing the number of identified lesions, SUVmax and background uptake between the FAPI and FDG PET/CT scans.

Timepoint [1] 408575 0
Once all the scans are assessed by the nuclear medicine radiologist.
Secondary outcome [2] 408576 0
Pancreatic cancer stage using FAPI PET/CT scan or FDG PET/CT scan assessed in accordance with the TNM Classification for Pancreatic Cancer
Timepoint [2] 408576 0
Once all the scans are assessed by the nuclear medicine radiologist.
Secondary outcome [3] 408578 0
Safety of FAPI PET/CT imaging modality, as assessed by monitoring the adverse events either observed by imaging staff or self-reported by patients documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE, v5.0).
To date there have been zero reports of adverse events, including drug-related pharmacologic effects, physiological responses or patient-reported symptoms, linked to FAPI administration in the available literature.

Timepoint [3] 408578 0
Monitored continuously from the time of tracer injection to 30mins post-PET/CT completion.

Eligibility
Key inclusion criteria
Inclusion criteria
• Minimum of 18 years of age
• Histologically or cytologically confirmed pancreatic cancer
• Under consideration for surgical resection by a Wesley HPB surgeon
• No treatment with chemotherapy, external beam radiation, immunotherapy and/or angiogenesis inhibitors for up to four weeks prior to study PET/CT scans
• Adequate renal function (A patient’s eGFR needs to be greater than 35mL/min/1.73m2 to receive CT contrast).
• Ability to understand and willingness to sign a written informed consent document
• Willing and able to comply with the two required PET/CT scans

This patient group has been selected as they represent a group in which current imaging methods for staging/restaging presents an unmet diagnostic challenge.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
• Pancreatic disease too advanced for surgical resection to be considered standard care
• Concurrent malignancies, except non-melanoma skin cancers
• Pregnant or breast feeding
• Participation would delay imminent conventional treatment
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to FAPI, FDG or intravenous iodinated contrast media
• Involvement in a clinical trial with an investigational agent which may reasonably interfere with the PET/CT imaging
• Uncontrolled intercurrent illness which may reasonably interfere with PET/CT imaging, including, but not limited to, active infection or inflammatory process

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The trial objectives will be addressed by the collection and analysis of data points obtained from patient characteristics, PET/CT scans, and reports.

For analysis purposes, data points will be assessed in three ways:
1) Intra-individual comparison of the two PET/CT scans to compare imaging on a per-patient basis
2) Cohort as a whole
3) Grouped by reason for the PET/CT scans (staging or restaging).

As this is an initial feasibility study with the primary aim of assessing the feasibility of FAPI PET/CT for pancreatic cancer, results will be preliminary only. Descriptive statistics will be used as appropriate, for example when presenting data on patient characteristics such as mean, median and range of patient age, and on other quantitative data points such as SUVmax.
No further statistical analysis is likely to be appropriate given the small size of this study. This is because this trial is designed as a feasibility study, with the objective of adding to the literature and being descriptive rather than definitive.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/05/2022
Actual
7/09/2022
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
7/09/2023
Actual
Sample size
Target
10
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22184 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 37337 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 311211 0
Other Collaborative groups
Name [1] 311211 0
Wesley Medical Research
Country [1] 311211 0
Australia
Funding source category [2] 311213 0
Commercial sector/Industry
Name [2] 311213 0
I-MED Radiology Network
Country [2] 311213 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
I-MED Radiology Network
Address
Level 1
Wesley Specialist Centre
87 Lang Pde
Auchenflower
QLD
4066
Country
Australia
Secondary sponsor category [1] 312581 0
None
Name [1] 312581 0
Address [1] 312581 0
Country [1] 312581 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310740 0
UnitingCare Human Research Ethics Committee
Ethics committee address [1] 310740 0
UnitingCare Health Human Research Ethics Committee
Ground Floor Moorlands House
The Wesley Hospital
451 Coronation Drive, Auchenflower QLD 4066
PO Box 499 Toowong QLD 4066
Ethics committee country [1] 310740 0
Australia
Date submitted for ethics approval [1] 310740 0
11/01/2022
Approval date [1] 310740 0
08/04/2022
Ethics approval number [1] 310740 0
202202

Summary
Brief summary
The aim of this study is to assess the feasibility, efficacy, and safety of a new type of cancer imaging called gallium-68 fibroblast activation protein inhibitor (68Ga-FAPI) positron emission tomography/computed tomography (PET/CT), compared to the standard of care cancer imaging called 18F-fluorodeoxyglucose (18F-FDG) PET/CT, for the staging/restaging (i.e. determining how much cancer is in the body and where it is) of pancreatic cancer.

Who is it for?
You may be eligible to participate in this study if you are aged 18 years or older, have histologically or cytologically confirmed pancreatic cancer, and are under consideration for surgical resection by a Wesley hepatopancreaticobiliary (HPB) surgeon.

Study details
All participants will undergo a FDG PET/CT scan at I-MED Radiology, The Wesley Hospital, as part of standard care. This will involve the injection of 2.5MBq/kg + 75MBq FDG tracer intravenously, followed by the PET/CT scan 60 minutes post tracer administration +/- 10minutes, and will take approximately 30 minutes to complete.
Within 1-7 days of the FDG PET/CT scan, a FAPI PET/CT scan will be performed at I-MED Radiology, The Wesley Hospital. This will involve the injection of 2.5MBq/kg FAPI tracer intravenously, followed by the PET/CT scan 60 minutes +/- 10 minutes later, and will take approximately 30 minutes to complete. The two scans will be compared for their ability to detect pancreatic cancer lesions and the effect of this on staging or restaging of the disease. Participants will also be monitored for side effects following injection of both tracers to determine the safety of each technique.

In conducting this study, we hope to provide proof-of-principle that FAPI PET/CT provides a clinically useful imaging modality for the staging/restaging of pancreatic cancer at The Wesley Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118702 0
Dr David Wong
Address 118702 0
I-MED Radiology
Level 2 Sandford Jackson Building
The Wesley Hospital
30 Chasely St
Auchenflower
QLD
4066
Country 118702 0
Australia
Phone 118702 0
+61419701900
Fax 118702 0
Email 118702 0
David.Wong@i-med.com.au
Contact person for public queries
Name 118703 0
Dr Sepinoud Firouzmand
Address 118703 0
Level 1
Wesley Specialist Centre
87 Lang Pde
Auchenflower
QLD
4066
Country 118703 0
Australia
Phone 118703 0
+61 7 3371 9588
Fax 118703 0
Email 118703 0
research@i-med.com.au
Contact person for scientific queries
Name 118704 0
Dr Sepinoud Firouzmand
Address 118704 0
Level 1
Wesley Specialist Centre
87 Lang Pde
Auchenflower
QLD
4066
Country 118704 0
Australia
Phone 118704 0
+61 7 3371 9588
Fax 118704 0
Email 118704 0
research@i-med.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Identifiable participant research data will only be shared with the study investigators.
Only de-identified aggregate data will be made available publicly via, e.g. publications/presentations.
Individual PET/CT results will be available to participants treating HPB surgeons (standard practice).
Minimal, de-identified research data will be provided to the manufacturer of the FAPI tracer.
When will data be available (start and end dates)?
Collected data will be available to the study investigators from the start of the study (31/05/2022) until the end of the study (including the time needed for data analysis and preparation of reports, papers, and presentations, i.e. at least until 30/11/2023).
Available to whom?
Identifiable participant research data will only be available to the study investigators.
Individual PET/CT results will be available to participants’ treating HPB surgeons (standard practice).
Minimal, de-identified information, including clinical information and data on safety, will be available to the manufacturer of the FAPI tracer (SOFIE Biosciences).
Available for what types of analyses?
Identifiable participant research data will only be available to the study investigators for statistical analyses and preparing reports, papers, publications, etc.
How or where can data be obtained?
The study investigators can obtain collected research data from the platforms on which data has been captured and stored.

De-identified individual participant data may be available to the manufacturer of the FAPI tracer on request via email to SOFIE Biosciences (e.g. Frank Valla Jr. Director, Clinical Development, Frank.Valla@sofie.com, website: https://sofie.com/).


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.