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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
 Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: αvβ3 Integrin Imaging with Fluciclatide (AH111585)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492192

Contacts
Contact: Linda Ward, BSc 44 (0) 1865 235302 earlyphasehub@oncology.ox.ac.uk

Locations
United Kingdom
Department of Radiology, Oxford University Hospitals NHS Trust Not yet recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Principal Investigator: Fergus Gleeson, MB BS FRCP/R            
Sub-Investigator: Neel Patel, MA BMBChFRCR            
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
GE Healthcare
University of Oxford
Investigators
Principal Investigator: Fergus Gleeson Oxford University Hospitals NHS Trust
  More Information

No publications provided

Responsible Party: Linda Ward, Quality Manager, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01492192     History of Changes
Other Study ID Numbers: EP-TSC-663, 2011-002833-20
Study First Received: December 12, 2011
Last Updated: March 28, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Oxford University Hospitals NHS Trust:
Angiogenesis
PET-CT
Perfusion-CT

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Kidney Diseases
Urologic Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013