RGD-PET-CT in Cancer Angiogenesis

October 30, 2017 updated by: Linda Ward, Oxford University Hospitals NHS Trust

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LJ
        • Department of Radiology, Oxford University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RCC Patients Antiangiogenic treatment
Drug: 18F-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

Other Names:
  • αvβ3 Integrin Imaging with Fluciclatide (AH111585)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
% 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
Time Frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
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
Time Frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Progression free survival at 12 months-
Time Frame: 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.
12 months after the final reseach scan.
Overall survival at 12 months
Time Frame: 12 months after the final reseach scan.
12 months after the final reseach scan.
Safety profile
Time Frame: within 12 months of the last research scan
Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)
within 12 months of the last research scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Collaborators

GE Healthcare
University of Oxford

Investigators

  • Principal Investigator: Fergus Gleeson, Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 12, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-TSC-663
  • 2011-002833-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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