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RGD-PET-CT in Cancer Angiogenesis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Oxford University Hospitals NHS Trust.
Recruitment status was:  Recruiting
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: July 1, 2014
Last verified: July 2014
  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
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:


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 ]

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 ]
  • 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)


Estimated Enrollment: 40
Study Start Date: May 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   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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

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 ( EudraCT Number )
Study First Received: December 12, 2011
Last Updated: July 1, 2014

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

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

ClinicalTrials.gov processed this record on March 28, 2017