A Phase 2 interventional study of 18F-RGD-PET-CT and perfusion CT scans on 3 occasions in Carcinoma, Renal Cell, sponsored by Oxford University Hospitals NHS Trust. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-01.
Sponsored by Oxford University Hospitals NHS Trust · Phase 2, Interventional, and Diagnostic
The goal of this clinical research study is to look at 2 new methods of scanning and see whether they can help researchers predict which tumours will respond to drugs that attack tumour blood supply.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 10 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Oxford University Hospitals NHS Trust is the lead sponsor of 92 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions
Fluciclatide (GE Healthcare) (AH111585) is a small cyclic peptide containing the RGD tripeptide (figure 1), which preferentially binds with high affinity to α¬vβ3 integrins that are up-regulated in angiogenesis. The IMP is supplied as a solution for injection, 400 MBq at the reference date and time. Participants will receive one injection of the imaging agent at this dose on 3 occasions
Also known as: αvβ3 Integrin Imaging with Fluciclatide (AH111585)
Changes in tumour uptake of the fluciclatide imaging agent
% change in SUVmax
Time frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Tumour response within an individual patient
% change in size
Time frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Changes of kinetic parameters on CT perfusion imaging
BV, BF and Ki
Time frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Absolute and relative tumour uptake and retention of fluciclatide
Time frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Progression free survival at 12 months-
Time from last study scan to the date of disease progression or death due to the disease,whichever occurs first.
Time frame: 12 months after the final reseach scan.
Overall survival at 12 months
Time frame: 12 months after the final reseach scan.
Safety profile
Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)
Time frame: within 12 months of the last research scan
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Oxford University Hospitals NHS Trust