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Trial registered on ANZCTR


Registration number
ACTRN12623000518662
Ethics application status
Approved
Date submitted
18/04/2023
Date registered
19/05/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical utility of [68Ga] fibroblast activation protein inhibitor (FAPI) positron emission tomography and computed tomography (PET/CT) in patients with potentially resectable pancreatic ductal adenocarcinoma (PDAC).
Scientific title
The clinical utility of [68Ga]-labelled fibroblast activation protein inhibitor (FAPI) positron emission tomography and computed tomography (PET/CT) in patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC) undergoing neoadjuvant chemotherapy.
Secondary ID [1] 307977 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer 329374 0
Condition category
Condition code
Cancer 326317 326317 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is evaluating a new radio-isotype, [68Ga] FAPI, thought to be more accurate than [18F] Fluorodeoxyglucose [FDG] isotype in staging of patients with pancreatic cancer.

All patients fulfilling inclusion criteria will be referred for PET/CT scanning as arranged by the coordinating investigator. Patients will first undergo [18F] FDG PET as part of pre-treatment workup, followed by [68 Ga] FAPI PET/CT, within approximately seven days.

[68 Ga] FAPI PET/CT Imaging Protocol:
The specific radio-isotype used is the [68 Ga]-FAPI-46 variant, and the dose is calculated according to the patient’s weight, 1.8–2.2 MBq/kg. Static PET/CT imaging will be performed using the Siemens PET/CT scanner 60 minutes after intravenous injection and includes the base of the skull to the upper thighs. A qualified nuclear medicine physicist will conduct the procedure and a Nuclear Medicine Radiologist will report the results of the scan. The entire duration of the scan is approximately 1h30mins.

Patients will then receive standard of care chemotherapy, and approximately 28 days after the patient has completed their fourth cycle of chemotherapy, patients will repeat a [18F] FDG PET/CT standard of care imaging, followed by a [68 Ga] FAPI PET/CT within approximately 7 days.

Following repeat PET/CT scanning, the patient’s response to chemotherapy will be discussed at the Hepatobiliary (HPB) multidisciplinary meeting and and the patient will be evaluated for surgery. If still deemed resectable, the patient will proceed to surgery. Resection specimens will undergo routine histological evaluation as per standard guidelines. After diagnostic requirements have been completed, IHC for FAP expression will be performed.

This is the end of the patient's participation in the trial. Patients will continue routine care and follow up with their regular Medical Oncologist and HPB Surgeon.
Intervention code [1] 325673 0
Diagnosis / Prognosis
Intervention code [2] 325909 0
Early detection / Screening
Comparator / control treatment
The comparator scan is [18F] FDG PET/CT.

[18F] FDG PET/CT Imaging Protocol:
FDG PET/CT imaging will be conducted after >6 hours of fasting and among patients with normal blood glucose levels. The dose of [18F] FDG is calculated according to the patient’s weight, 3.7MBq/kg. Static PET/CT imaging will be performed using the Siemens PET/CT scanner 60 minutes after intravenous injection and will include the skull base to upper thighs. A qualified nuclear medicine physicist will conduct the procedure and a Nuclear Medicine Radiologist will report the results of the scan. The entire duration of the scan is approximately 1h30mins.

FDG PET/CT scan is part of the patient's standard of care imaging pre and post chemotherapy.
Control group
Active

Outcomes
Primary outcome [1] 334470 0
Diagnostic efficacy for pancreatic ductal adenocarcinoma
Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for pancreatic cancer in comparison with 18F-FDG PET/CT pre- and post- chemotherapy
Timepoint [1] 334470 0
1 week and 12 weeks after enrolment
Primary outcome [2] 334770 0
Maximum standardized uptake value (SUVmax)
SUVmax of 68Ga-FAPI PET/CT in patients with pancreatic cancer in comparison with 18F-FDG PET/CT pre- and post - chemotherapy
Timepoint [2] 334770 0
1 week and 12 weeks after enrolment
Secondary outcome [1] 420812 0
Percentage of fibroblast activation protein (FAP) expression
Percentage of FAP expression in the pre-treatment biopsy specimen and the post chemotherapy resected specimen
Timepoint [1] 420812 0
16 weeks after enrolment
Secondary outcome [2] 420814 0
Sensitivity of FAPI PET/CT SUVmax assessed by correlation between the expression of fibroblast activation protein (FAP) in pre-and post treatment tissue specimens and 68Ga-FAPI uptake.
Analysing the correlation between the SUVmax of 68Ga-FAPI in pancreatic lesions, with FAP expression in pre and post treatment tissue specimens.
Timepoint [2] 420814 0
16 weeks post enrolment

Eligibility
Key inclusion criteria
- Age greater than or equal to 18years
- Able to give informed consent
- Histological specimen from the primary pancreatic lesion confirming the diagnosis of PDAC.
- Patients need to have either a resectable or borderline resectable pancreatic lesion after imaging review at the HPB multidisciplinary (MDT) meeting
- No metastatic disease
- Eastern Cooperative Oncology Group performance status of less than or equal to 1
- No contraindications to neoadjuvant chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients not medically fit for peri-operative chemotherapy with FOLFIRINOX or surgery
- Patients with known or suspected metastatic disease
- Pregnant or breastfeeding patients (if a female patient is pre-menopausal, she will require a negative urine pregnancy test prior to enrolment)
- Patients with allergies to or contraindications to [68 Ga] FAPI or [18F] FDG tracer
- Patients who have had surgery or chemotherapy prior to 1st PET/CT imaging.

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
- Descriptive statistics (frequencies and percentages) will be reported for categorical variables and interquartile range (IQR) will be reported for continuous variables.
- We will compare the SUVmax response using a paired t-test or Wilcoxon rank-sum test
- For the patients’ tissue analysis, we will perform linear regression, adjusting for potential confounders to determine if proportion and intensity of staining is related to SUVmax of primary pancreatic lesions. We will do this separately for both stromal and neoplastic expression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24533 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 40125 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 312246 0
Government body
Name [1] 312246 0
Metro-South Health
Country [1] 312246 0
Australia
Funding source category [2] 313656 0
Other Collaborative groups
Name [2] 313656 0
Translational research institute
Country [2] 313656 0
Australia
Funding source category [3] 313657 0
Other
Name [3] 313657 0
Research Fund Cost Centre - 80000312
Country [3] 313657 0
Australia
Primary sponsor type
Government body
Name
Metro South Health
Address
199, Ipswich Road
Wooloongabba, QLD, 4102
Country
Australia
Secondary sponsor category [1] 315450 0
None
Name [1] 315450 0
Address [1] 315450 0
Country [1] 315450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311621 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 311621 0
Ethics committee country [1] 311621 0
Australia
Date submitted for ethics approval [1] 311621 0
15/09/2022
Approval date [1] 311621 0
16/12/2022
Ethics approval number [1] 311621 0
HREC/2022/QMS/89855
Ethics committee name [2] 312824 0
University of Queensland Research Governance
Ethics committee address [2] 312824 0
Ethics committee country [2] 312824 0
Australia
Date submitted for ethics approval [2] 312824 0
12/01/2023
Approval date [2] 312824 0
15/03/2023
Ethics approval number [2] 312824 0
2022/HE002545

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

Contacts
Principal investigator
Name 121750 0
Prof Victoria Atkinson
Address 121750 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, QLD, 4102
Country 121750 0
Australia
Phone 121750 0
+61 7 3176 5159
Fax 121750 0
Email 121750 0
victoria.atkinson@health.qld.gov.au
Contact person for public queries
Name 121751 0
Catherine Berman
Address 121751 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, QLD, 4102
Country 121751 0
Australia
Phone 121751 0
+61 7 3176 2111
Fax 121751 0
Email 121751 0
catherine.berman@health.qld.gov.au
Contact person for scientific queries
Name 121752 0
Catherine Berman
Address 121752 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, QLD, 4102
Country 121752 0
Australia
Phone 121752 0
+61 7 3176 2111
Fax 121752 0
Email 121752 0
catherine.berman@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only the study investigators assigned to this research will have access to patients information


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18887Study protocol    384673-(Uploaded-18-04-2023-13-11-42)-Study-related document.pdf
18888Informed consent form    384673-(Uploaded-18-04-2023-13-12-54)-Study-related document.pdf
18889Ethical approval    384673-(Uploaded-18-04-2023-13-13-40)-Study-related document.pdf
18926Ethical approval    384673-(Uploaded-18-04-2023-13-23-52)-Study-related document.pdf



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.