RGD-PET-CT in Cancer Angiogenesis

Carcinoma, Renal Cell Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01492192
• Other study ID #: EP-TSC-663
• Secondary ID: 2011-002833-20
• Status: Terminated
• Phase: Phase 2
• First received: December 12, 2011
• Last updated: October 30, 2017
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2017
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

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 a¬vß3 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

Locations

Country	Name	City	State
United Kingdom	Department of Radiology, Oxford University Hospitals NHS Trust	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	GE Healthcare, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in tumour uptake of the fluciclatide imaging agent	% change in SUVmax	Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Secondary	Tumour response within an individual patient	% change in size	Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Secondary	Changes of kinetic parameters on CT perfusion imaging	BV, BF and Ki	Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Secondary	Absolute and relative tumour uptake and retention of fluciclatide		Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Secondary	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.	12 months after the final reseach scan.
Secondary	Overall survival at 12 months		12 months after the final reseach scan.
Secondary	Safety profile	Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)	within 12 months of the last research scan