Carcinoma, Renal Cell
Conditions
Keywords
Angiogenesis, PET-CT, Perfusion-CT
Brief summary
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.
Interventions
DRUG18F-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
Sponsors
GE Healthcare
University of Oxford
Oxford University Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients should have advanced or metastatic RCC confirmed by histological diagnosis 2. Patients considered suitable for therapy with TKI for RCC according to responsible clinician 3. Measurable tumour according to RECIST v1.1 criteria 4. Standard staging CT scan performed within 28 days of first research scan 5. The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment 6. Age ≥18 years 7. Adequate renal function (creatinine \<1.25xULN) 8. Patient is able to tolerate and comply with scanning procedure 9. Patient is not lactating or pregnant 10. Absence of any psychological, familial, sociological or geographical condition which in the opinion of the Investigator may potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 11. Able and willing to give informed consent
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in tumour uptake of the fluciclatide imaging agent | Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment | % change in SUVmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of kinetic parameters on CT perfusion imaging | Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment | BV, BF and Ki |
| Absolute and relative tumour uptake and retention of fluciclatide | Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment | — |
| Tumour response within an individual patient | Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment | % change in size |
| Overall survival at 12 months | 12 months after the final reseach scan. | — |
| Safety profile | within 12 months of the last research scan | Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria) |
| Progression free survival at 12 months- | 12 months after the final reseach scan. | Time from last study scan to the date of disease progression or death due to the disease,whichever occurs first. |
Countries
United Kingdom
Outcome results
None listed