Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2013-05-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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RCC Patients Antiangiogenic treatment
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 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
Interventions
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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 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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GE Healthcare
INDUSTRY
University of Oxford
OTHER
Oxford University Hospitals NHS Trust
OTHER
Responsible Party
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Linda Ward
Quality Manager
Principal Investigators
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Fergus Gleeson
Role: PRINCIPAL_INVESTIGATOR
Oxford University Hospitals NHS Trust
Locations
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Department of Radiology, Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom
Countries
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Other Identifiers
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2011-002833-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EP-TSC-663
Identifier Type: -
Identifier Source: org_study_id