RGD-PET-CT in Cancer Angiogenesis

This study is not yet open for participant recruitment.
Verified March 2013 by Oxford University Hospitals NHS Trust
Sponsor:
Collaborators:
GE Healthcare
University of Oxford
Information provided by (Responsible Party):
Linda Ward, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01492192
First received: December 12, 2011
Last updated: March 28, 2013
Last verified: March 2013

December 12, 2011
March 28, 2013
April 2013
February 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01492192 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • • 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. ] [ Designated as safety issue: No ]
  • Overall survival at 12 months [ Time Frame: 12 months after the final reseach scan. ] [ Designated as safety issue: No ]
  • safety profile [ Time Frame: within 12 months of the last research scan ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)
Same as current
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
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Not yet recruiting
40
February 2017
February 2016   (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:

  • Not applicable
Both
18 Years and older
No
Contact: Linda Ward, BSc 44 (0) 1865 235302 earlyphasehub@oncology.ox.ac.uk
United Kingdom
 
NCT01492192
EP-TSC-663, 2011-002833-20
Yes
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
March 2013

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