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Prospective Study of 18F-RGD PET-CT in Assessment of Response to Antiangiogenic Treatment in Patients With Cancer and Comparison With Perfusion CT


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

Prospective Study of 18F-RGD PET-CT in Assessment of Response to Antiangiogenic Treatment in Patients With Cancer and Comparison With Perfusion CT


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Changes in tumour uptake (% change in SUVmax) of the fluciclatide imaging agent

Outcome Time Frame:

Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment

Safety Issue:

No

Principal Investigator

Fergus Gleeson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oxford University Hospitals NHS Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

EP-TSC-663

NCT ID:

NCT01492192

Start Date:

April 2013

Completion Date:

February 2017

Related Keywords:

  • Carcinoma, Renal Cell
  • Angiogenesis
  • PET-CT
  • Perfusion-CT
  • Carcinoma
  • Carcinoma, Renal Cell

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