68Gallium-Prostate Specific Membrane Antigen (68Ga-PSMA) Positron Emission Tomography (PET) as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal cell Carcinoma (PIRC) – a pilot study
- Conditions
- clear cell renal cell carcinomaCancer - Kidney
- Registration Number
- ACTRN12621000651886
- Lead Sponsor
- Olivia Newton-John Cancer Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
18 years of age or older
- histologically confirmed unresectable/metastatic clear-cell renal cell carcinoma; variant-histology allowed as long as a clear-cell component comprises >50% of the tumour.
- previous treatment with at least one anti-VEGF TKI, with radiographic disease progression (by RECIST 1.1) confirmed whilst on or within 6 months of this treatment. Previous treatment(s) with an ICI, chemotherapy or, cytokine therapy, allare permitted.
- planned for commencement of a subsequent anti-VEGF TKI treatment as monotherapy.
- at least one measurable lesion by RECIST 1.1, not treated or planned for treatment by external beam radiation therapy.
- adequate kidney/liver function: bilirubin < 1.5 x ULN, AST/ALT < 2.5 x ULN, Creatinine < 1.5 x ULN
- able to tolerate PET scan procedures
- life expectancy > 3 months as estimated by the investigator
- no history of other active malignancies in prior 2 years
- not eligible for a subsequent anti-VEGF TKI therapy in the opinion of the treating clinician, due to any reason
- about to commence treatment with anti-VEGF TKI therapy in combination with another therapy (e.g. other pathway inhibitor or ICI)
- previous adverse reaction to 68Ga-PSMA
- not able to provide informed consent
- pregnant or currently lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method