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Clinical Trials/NCT01492192
NCT01492192TerminatedPhase 2

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 enrollmentStarted: May 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
10
Locations
1
Primary Endpoint
Changes in tumour uptake of the fluciclatide imaging agent
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

RCC Patients Antiangiogenic treatment

Experimental

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

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Linda Ward

Quality Manager

Oxford University Hospitals NHS Trust

Study Sites (1)

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