RGD-PET-CT in Cancer Angiogenesis

Phase 2

Terminated

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions

• Registration Number: NCT01492192
• Lead Sponsor: Oxford University Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Study Start: 2013-05
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RCC Patients Antiangiogenic treatment	18F-RGD-PET-CT and perfusion CT scans on 3 occasions	-

Primary Outcome Measures

Name	Time	Method
Changes in tumour uptake of the fluciclatide imaging agent	Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment	% change in SUVmax

Secondary Outcome Measures

Name	Time	Method
Tumour response within an individual patient	Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment	% change in size
Changes of kinetic parameters on CT perfusion imaging	Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment	BV, BF and Ki
Progression free survival at 12 months-	12 months after the final reseach scan.	Time from last study scan to the date of disease progression or death due to the disease,whichever occurs first.
Overall survival at 12 months	12 months after the final reseach scan.
Safety profile	within 12 months of the last research scan	Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)
Absolute and relative tumour uptake and retention of fluciclatide	Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment

Trial Locations

Locations (1)

Department of Radiology, Oxford University Hospitals NHS Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom