68Ga-PSMA PET as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal cell Carcinoma (PIRC) – a pilot study

Olivia Newton-John Cancer Research Institute0 个研究点目标入组 20 人开始时间: 2021年5月31日最近更新: 2022年5月23日

适应症

试验速览

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•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

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