ACTRN12621000651886
Recruiting
未知
68Ga-PSMA PET as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal cell Carcinoma (PIRC) – a pilot study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Olivia Newton-John Cancer Research Institute
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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