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Trial registered on ANZCTR


Registration number
ACTRN12624000155594
Ethics application status
Approved
Date submitted
12/01/2024
Date registered
16/02/2024
Date last updated
6/07/2024
Date data sharing statement initially provided
16/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scan vs Fludeoxyglucose (FDG) PET scan when assessing for spread of kidney tumours
Scientific title
ProspEctive comparison of Prostate Specific Membrane Antigen (PSMA) PET CT vs Fludeoxyglucose (FDG) PET CT in staging of Renal Tumours (PEPPER): a pilot trial.
Secondary ID [1] 310975 0
nil
Universal Trial Number (UTN)
Trial acronym
PEPPER Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal tumours 332561 0
Condition category
Condition code
Cancer 329261 329261 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following enrolment, all participants will be staged with two PET scans within 21 days of enrolment:
1. PSMA PET/CT scan (Prostate Specific Membrane Antigen Positron Emission Tomography/Computed Tomography scan) performed at the Royal Brisbane and Women's Hospital
2. FDG PET/CT (Fludeoxyglucose Positron Emission Tomography/Computed Tomography). performed at Herston Imaging Research Facility.
Scans take approximately 1 hour and can be performed on the same day depending upon availability.
Both scans will be reported by Nuclear Medicine Specialists with sub-specialty interest in urological malignancies blinded from the results of the other PET if performed first, but not blinded from the original CT to reflect real-world practice.
PET scan reports will include primary tumour maximum standardised uptake valve (SUVmax), Staging according to the latest Tumour, Nodes, Metastases (TNM) staging for renal cell carcinoma. The location of any metastases will be recorded. Reporters will also record their confidence in the findings according to a 4 point scale (from definitely positive to definitely negative).
After reporting of both PET scans, Nuclear Medicine Specialists will be unblinded from all scans. Where the reports are discordant, scans will be reviewed through the Royal Brisbane and Women's Hospital Multi-disciplinary Team meeting. A consensus report will be issued based upon all available imaging to provide participants with the best available staging to optimise management
Intervention code [1] 327759 0
Diagnosis / Prognosis
Comparator / control treatment
The current standard scan is a CT, which is part of the inclusion criteria. Both PSMA and FDG PET scans remain experimental in this field.
CT scans are performed within 6 weeks prior to recruitment.
Control group
Active

Outcomes
Primary outcome [1] 337082 0
Proportion of patients whose management is changed by addition PSMA to conventional CT scan.
Timepoint [1] 337082 0
21 (+/- 7) days following enrollment
Primary outcome [2] 337416 0
Proportion of patients whose management is changed by addition FDG PET to conventional CT scan.
Timepoint [2] 337416 0
21 (+/- 7) days following enrollment
Secondary outcome [1] 430599 0
Proportion of discordant PET scans favouring PSMA vs proportion favouring FDG.
Timepoint [1] 430599 0
21 (+/- 7) days, 6 months and 12 months post-enrolment
Secondary outcome [2] 430600 0
To determine the proportion of renal tumours which are PSMA avid by histological subtype
Timepoint [2] 430600 0
6 months post-enrolment
Secondary outcome [3] 430601 0
Change in EQ-5D-5L quality of life assessment following PET scans
Timepoint [3] 430601 0
Baseline, 21 (+/- 7) days post-enrolment
Secondary outcome [4] 431284 0
To determine the proportion of patients whose disease stage is altered by PSMA PET scan compared to CT
Timepoint [4] 431284 0
21 (+/- 7) days, 6 month and 12 months post-enrolment
Secondary outcome [5] 431285 0
To determine the predictive value of PSMA PET compared to CT for lymph node disease
Timepoint [5] 431285 0
21 (+/-7) days, 6 month and 12 months post-enrolment
Secondary outcome [6] 431286 0
To determine if tumour SUV max on PSMA PET can predict tumour grade
Timepoint [6] 431286 0
6 months post-enrolment
Secondary outcome [7] 431781 0
To determine the proportion of renal tumours which are FDG avid by histological subtype
Timepoint [7] 431781 0
6 months post enrollment
Secondary outcome [8] 431784 0
To determine the proportion of patients whose disease stage is altered by FDG PET scan compared to CT
Timepoint [8] 431784 0
21 (+/- 7) days, 6 month and 12 months post-enrolment
Secondary outcome [9] 431785 0
To determine the predictive value of PSMA PET compared to CT for metastatic disease
Timepoint [9] 431785 0
21 (+/-7) days, 6 month and 12 months post-enrolment
Secondary outcome [10] 431786 0
To determine the predictive value of FDG PET compared to CT for lymph node disease
Timepoint [10] 431786 0
21 (+/-7) days, 6 month and 12 months post-enrolment
Secondary outcome [11] 431787 0
To determine the predictive value of FDG PET compared to CT for metastatic disease
Timepoint [11] 431787 0
21 (+/-7) days, 6 month and 12 months post-enrolment
Secondary outcome [12] 431788 0
To determine if tumour SUV max on FDG PET can predict tumour grade
Timepoint [12] 431788 0
6 months post enrollment
Secondary outcome [13] 431789 0
To determine if tumour SUV max on PSMA PET can predict risk of metastases at 12 months
Timepoint [13] 431789 0
12 months post enrollment
Secondary outcome [14] 431792 0
To determine if tumour SUV max on FDG PET can predict risk of metastases at 12 months
Timepoint [14] 431792 0
12 months post enrollment

Eligibility
Key inclusion criteria
Aged 18 years or older
Renal tumours >7cm, or cT3/4 and/or cN1 or equivocal retroperitoneal lymph node involvement on CT
M0 or equivocal on CT chest, abdomen, pelvis within 6 weeks prior to recruitment
Able to provide informed consent
Willing and able to comply with study protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of other active malignancy within last 2 years, excluding non-melanoma cutaneous neoplasms
Renal tumours having an atypical appearance where an alternative diagnosis is felt to be more likely eg urothelial carcinoma
PSMA or FDG PET in the preceding 2 years.
Significant co-morbidity or other barrier to completing study processes
Patients with renal masses with IVC tumour thrombus if awaiting PET scans will cause unnecessary surgical delay
Pregnancy, or planning pregnancy in the next 6 months.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Intra-individual comparison of CT scan (standard care), PSMA PET (experimental) and FDG PET (experimental)
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
1/03/2026
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
30
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26009 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 26010 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 41856 0
4029 - Herston
Recruitment postcode(s) [2] 41857 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 315234 0
Hospital
Name [1] 315234 0
RBWH Urology Research Fund
Country [1] 315234 0
Australia
Primary sponsor type
Hospital
Name
Metro North HHS
Address
L14, Block 7, RBWH, Herston Q 4029
Country
Australia
Secondary sponsor category [1] 317266 0
None
Name [1] 317266 0
Address [1] 317266 0
Country [1] 317266 0
Other collaborator category [1] 282926 0
Other Collaborative groups
Name [1] 282926 0
Herston Imaging Research Facility
Address [1] 282926 0
L3, UQCCR Building 71/918, Royal Brisbane & Women's Hospital, Herston QLD 4006
Country [1] 282926 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314158 0
Metro North HREC B
Ethics committee address [1] 314158 0
Research Office Building 14 Rode Road CHERMSIDE QLD 4032
Ethics committee country [1] 314158 0
Australia
Date submitted for ethics approval [1] 314158 0
30/10/2023
Approval date [1] 314158 0
22/02/2024
Ethics approval number [1] 314158 0
HREC/2023/MNHB/103197

Summary
Brief summary
The purpose of this study is to determined whether the addition of a PET scan to conventional CT scans improves the diagnostic accuracy and/or changes the management for patients newly found to have a kidney tumour.

Who is it for?
You may be eligible if you are an adult who has recently been diagnosed with a kidney tumour.

Study details
PET scans work by injecting a "tracer" that accumulates in specific tissue types and show as "hot spots" on a scan. We will be comparing two types of tracer that have been shown to have affinity for renal tumours: Prostate-Specific Membrane Antigen (PSMA) and Fludeoxyglucose (FDG).

As such all participants in this study will be asked to have both a PSMA PET and an FDG PET within 21 days of enrolment. The scans may be performed on the same day, or require different visits.
There is a small risk of bruising or infection at the injection site. Each scan involves a small radiation dose which is within safe limits.
Participants will also complete a health-related quality of life questionnaire at enrolment and after completing the scans.

It is hoped that this study will determine whether PET scans will improve diagnostic accuracy both by identifying areas of tumour not seen on CT, and by ruling out areas that are suspicious on CT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130622 0
Dr Adam Pearce
Address 130622 0
Urology Dept, L1 James Mayne Building, RBWH, Butterfield St, Herston, Q 4006
Country 130622 0
Australia
Phone 130622 0
+61 7 3646 5772
Fax 130622 0
Email 130622 0
[email protected]
Contact person for public queries
Name 130623 0
Adam Pearce
Address 130623 0
Urology Dept, L1 James Mayne Building, RBWH, Butterfield St, Herston, Q 4006
Country 130623 0
Australia
Phone 130623 0
+61 7 3646 5772
Fax 130623 0
Email 130623 0
[email protected]
Contact person for scientific queries
Name 130624 0
Adam Pearce
Address 130624 0
Urology Dept, L1 James Mayne Building, RBWH, Butterfield St, Herston, Q 4006
Country 130624 0
Australia
Phone 130624 0
+61 7 3646 5772
Fax 130624 0
Email 130624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain participant privacy and confidentiality


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.