None listed
Conditions
Brief summary
This study is investigating the usefulness of a new type of positron emission tomography (PET) scan, targeting “prostate specific membrane antigen” (PSMA), in patients being treated for metastatic clear-cell renal cell carcinoma. Who is it for? You may be eligible for this study if you are 18 years of age or older and have metastatic clear-cell renal cell carcinoma, are about to commence treatment with at an anti-VEGF TKI and can tolerate PET scan procedures. Study details Participants will undergo usual standard of care treatment including standard CT diagnostic imaging and blood tests, which all treatment decisions will be based upon. They will also undergo a PSMA-PET scan at 3 timepoints; baseline, 4 weeks and 12 weeks, and these results will purely be for research use. The additional PSMA-PET scans are anticipated to take approx 180 mins and will involve injection of a small dose of radioactive tracer into one of your veins. Information from this study will be used to better understand whether such PSMA-PET scans are useful for visualising patients’ tumours after they have been treated.
Interventions
Following enrollment on study, 68 Gallium radiolabelled PSMA ligand will be administered by intravenous infusion followed by a Positron Emission Tomography (PET) scan at baseline (prior to standard of care TKI treatment), at 4 weeks and 12 weeks. 68Ga-PSMA (200MBq) will be administered by a nuclear medicine physician, PET images will be acquired by nuclear medicine technicians at the site. Total administered dose will be quantified and recorded by subtraction of residual dose (in infusion equip
Following enrollment on study, 68 Gallium radiolabelled PSMA ligand will be administered by intravenous infusion followed by a Positron Emission Tomography (PET) scan at baseline (prior to standard of care TKI treatment), at 4 weeks and 12 weeks. 68Ga-PSMA (200MBq) will be administered by a nuclear medicine physician, PET images will be acquired by nuclear medicine technicians at the site. Total administered dose will be quantified and recorded by subtraction of residual dose (in infusion equipment). PET images will be reviewed to confirm target lesion uptake. Standard of care activities include: computed tomography (CT) scans at baseline and approx. 12 weeks (+/- 7 days), haematology/biochemistry (up to 28 days before starting on study), physical exam and analysis of performance status.
Sponsors
Olivia Newton-John Cancer Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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. - planned for commencement of an anti-VEGF TKI treatment as monotherapy or in combination with other therapy, such as immunotherapy - at least one measurable lesion by RECIST 1.1, not treated or planned for treatment by external beam radiation therapy or another local modality such as surgery or radiofrequency ablation. - 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
- previous adverse reaction to 68Ga-PSMA - not able to provide informed consent - pregnant or currently lactating
Outcome results
None listed