Clinical trial NCT01492192: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Angiogenesis
PET-CT
Perfusion-CT
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: GE Healthcare
name: University of Oxford
First posted: 2011-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Changes in tumour uptake of the fluciclatide imaging agent
timeFrame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Secondary outcomes:
measure: Tumour response within an individual patient
timeFrame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
measure: Changes of kinetic parameters on CT perfusion imaging
timeFrame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
measure: Absolute and relative tumour uptake and retention of fluciclatide
timeFrame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
measure: Progression free survival at 12 months-
timeFrame: 12 months after the final reseach scan.
measure: Overall survival at 12 months
timeFrame: 12 months after the final reseach scan.
measure: Safety profile
timeFrame: within 12 months of the last research scan
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Department of Radiology, Oxford University Hospitals NHS Trust
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Fergus Gleeson
role: PRINCIPAL_INVESTIGATOR
References: