We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

RGD-PET-CT in Cancer Angiogenesis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492192
First Posted: December 14, 2011
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
GE Healthcare
University of Oxford
Information provided by (Responsible Party):
Linda Ward, Oxford University Hospitals NHS Trust
December 12, 2011
December 14, 2011
November 1, 2017
May 2013
September 2015   (Final data collection date for primary outcome measure)
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
Changes in tumour uptake (% change in SUVmax) of the fluciclatide imaging agent [ Time Frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment ]
Complete list of historical versions of study NCT01492192 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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 ]
  • 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.
  • Overall survival at 12 months [ Time Frame: 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)
  • Tumour response (% change in size) within an individual patient [ Time Frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment ]
  • Changes of kinetic parameters (BV, BF and Ki) on CT perfusion imaging [ Time Frame: 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 ]
  • • Progression free survival at 12 months- defined as 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. ]
  • Overall survival at 12 months [ Time Frame: 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)
Not Provided
Not Provided
 
RGD-PET-CT in Cancer Angiogenesis
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Carcinoma, Renal Cell
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 Name: αvβ3 Integrin Imaging with Fluciclatide (AH111585)
Experimental: RCC Patients Antiangiogenic treatment
Intervention: Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
September 2015
September 2015   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01492192
EP-TSC-663
2011-002833-20 ( EudraCT Number )
Yes
Not Provided
Not Provided
Linda Ward, Oxford University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
  • GE Healthcare
  • University of Oxford
Principal Investigator: Fergus Gleeson Oxford University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP