None listed
Conditions
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.
Interventions
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
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
Sponsors
Metro North HHS
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed