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RGD-PET-CT in Cancer Angiogenesis

Primary Purpose

Carcinoma, Renal Cell

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
18F-RGD-PET-CT and perfusion CT scans on 3 occasions
Sponsored by
Oxford University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Renal Cell focused on measuring Angiogenesis, PET-CT, Perfusion-CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Radiology, Oxford University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RCC Patients Antiangiogenic treatment

Arm Description

Outcomes

Primary Outcome Measures

Changes in tumour uptake of the fluciclatide imaging agent
% change in SUVmax

Secondary Outcome Measures

Tumour response within an individual patient
% change in size
Changes of kinetic parameters on CT perfusion imaging
BV, BF and Ki
Absolute and relative tumour uptake and retention of fluciclatide
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.
Overall survival at 12 months
Safety profile
Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)

Full Information

First Posted
December 12, 2011
Last Updated
October 30, 2017
Sponsor
Oxford University Hospitals NHS Trust
Collaborators
GE Healthcare, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT01492192
Brief Title
RGD-PET-CT in Cancer Angiogenesis
Official Title
Prospective Study of 18F-RGD PET-CT in Assessment of Response to Antiangiogenic Treatment in Patients With Cancer and Comparison With Perfusion CT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust
Collaborators
GE Healthcare, University of Oxford

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Angiogenesis, PET-CT, Perfusion-CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RCC Patients Antiangiogenic treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
18F-RGD-PET-CT and perfusion CT scans on 3 occasions
Other Intervention Name(s)
αvβ3 Integrin Imaging with Fluciclatide (AH111585)
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in tumour uptake of the fluciclatide imaging agent
Description
% change in SUVmax
Time Frame
Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Secondary Outcome Measure Information:
Title
Tumour response within an individual patient
Description
% change in size
Time Frame
Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Title
Changes of kinetic parameters on CT perfusion imaging
Description
BV, BF and Ki
Time Frame
Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Title
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
Title
Progression free survival at 12 months-
Description
Time from last study scan to the date of disease progression or death due to the disease,whichever occurs first.
Time Frame
12 months after the final reseach scan.
Title
Overall survival at 12 months
Time Frame
12 months after the final reseach scan.
Title
Safety profile
Description
Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)
Time Frame
within 12 months of the last research scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Able and willing to give informed consent Exclusion Criteria: Not applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fergus Gleeson
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology, Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

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RGD-PET-CT in Cancer Angiogenesis

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