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

Oxford University Hospitals NHS Trust1 site in 1 country10 target enrollmentMay 2013

ConditionsCarcinoma, Renal Cell

Interventions18F-RGD-PET-CT and perfusion CT scans on 3 occasions

Drugs18F-RGD-PET-CT and perfusion CT scans on 3 occasions

Overview

Phase: Phase 2
Intervention: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions
Conditions: Carcinoma, Renal Cell
Sponsor: Oxford University Hospitals NHS Trust
Enrollment: 10
Locations: 1
Primary Endpoint: Changes in tumour uptake of the fluciclatide imaging agent
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

September 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oxford University Hospitals NHS Trust

Responsible Party

Principal Investigator

Linda Ward

Quality Manager

Oxford University Hospitals NHS Trust

Eligibility Criteria

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

Exclusion Criteria

•Not applicable

Arms & Interventions

RCC Patients Antiangiogenic treatment

Intervention: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions

Outcomes

Primary Outcomes

Changes in tumour uptake of the fluciclatide imaging agent

Time Frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment

% change in SUVmax

Secondary Outcomes

Tumour response within an individual patient(Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment)
Changes of kinetic parameters on CT perfusion imaging(Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment)
Progression free survival at 12 months-(12 months after the final reseach scan.)
Overall survival at 12 months(12 months after the final reseach scan.)
Safety profile(within 12 months of the last research scan)
Absolute and relative tumour uptake and retention of fluciclatide(Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment)