RGD-PET-CT in Cancer Angiogenesis

Phase 2TerminatedNCT01492192

Oxford University Hospitals NHS Trust10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Carcinoma, Renal Cell

Interventions

18F-RGD-PET-CT and perfusion CT scans on 3 occasionsDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Radiology, Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, United Kingdom

Outcomes

Primary Outcomes

Changes in tumour uptake of the fluciclatide imaging agent

% change in SUVmax

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

Secondary Outcomes

Tumour response within an individual patient

% change in size

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

Changes of kinetic parameters on CT perfusion imaging

BV, BF and Ki

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-

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

Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)

Time frame: within 12 months of the last research scan

Data from ClinicalTrials.gov

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