RGD-PET-CT in Cancer Angiogenesis

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study of 18F-RGD PET-CT in Assessment of Response to Antiangiogenic Treatment in Patients With Cancer and Comparison With Perfusion CT

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should have advanced or metastatic RCC confirmed by histological diagnosis Patients considered suitable for therapy with TKI for RCC according to responsible clinician Measurable tumour according to RECIST v1.1 criteria Standard staging CT scan performed within 28 days of first research scan The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment Age ≥18 years Adequate renal function (creatinine <1.25xULN) Patient is able to tolerate and comply with scanning procedure Patient is not lactating or pregnant 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 Able and willing to give informed consent Exclusion Criteria: Not applicable

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RCC Patients Antiangiogenic treatment<br> | Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions<br>* 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<br>* Other names: αvβ3 Integrin Imaging with Fluciclatide (AH111585);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tumour uptake of the fluciclatide imaging agent | % change in SUVmax | Prior to starting anti-angiogenic treatment, repeat after  4 and 16 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response within an individual patient | % change in size | 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 | Prior to starting anti-angiogenic treatment, repeat after  4 and 16 weeks of treatment | 
| Absolute and relative tumour uptake and retention of fluciclatide |  | 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. | 12 months after the final reseach scan. | 
| Overall survival at 12 months |  | 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) | within 12 months of the last research scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angiogenesis, PET-CT, Perfusion-CT