NCT01492192

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

December 12, 2011

Last Update Submit

October 30, 2017

Conditions

Carcinoma, Renal Cell

Keywords

AngiogenesisPET-CTPerfusion-CT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • 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-

    12 months after the final reseach scan.

  • Overall survival at 12 months

    12 months after the final reseach scan.

  • +1 more secondary outcomes

Study Arms (1)

RCC Patients Antiangiogenic treatment

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

Interventions

18F-RGD-PET-CT and perfusion CT scans on 3 occasionsDRUG

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)
RCC Patients Antiangiogenic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

AH 111585

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Fergus Gleeson

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Quality Manager

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

May 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

GB(1)