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Clinical Trials/ACTRN12621000651886
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

Olivia Newton-John Cancer Research Institute0 sites20 target enrollmentMay 31, 2021

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.

Registry
who.int
Start Date
May 31, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

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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