Carcinoma, Renal CellPhase 2NCT01492192
RGD-PET-CT in Cancer Angiogenesis
A Phase 2 study testing 18F-RGD-PET-CT and perfusion CT scans on 3 occasions in people with Carcinoma, Renal Cell, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- 18F-RGD-PET-CT and perfusion CT scans on 3 occasions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should have advanced or metastatic RCC confirmed by histological diagnosis
- Patients considered suitable for therapy with TKI for RCC according to responsible clinician
- Measurable tumour according to RECIST v1.1 criteria
- Standard staging CT scan performed within 28 days of first research scan
- The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment
- Age ≥18 years
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- Adequate renal function (creatinine <1.25xULN)
- Patient is able to tolerate and comply with scanning procedure
- Patient is not lactating or pregnant
- 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
- Able and willing to give informed consent
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Radiology, Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LJ
About this study
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
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.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- 18F-RGD-PET-CT and perfusion CT scans on 3 occasions
- Keywords
- Angiogenesis, PET-CT, Perfusion-CT
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-RGD-PET-CT and perfusion CT scans on 3 occasionsDrug
Also called αvβ3 Integrin Imaging with Fluciclatide (AH111585)
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
| Study group | Role | What they receive |
|---|---|---|
| RCC Patients Antiangiogenic treatment | Experimental | Not described Receives: Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tumour uptake of the fluciclatide imaging agent
% change in SUVmax
Measured: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Secondary outcomes (6)
Tumour response within an individual patient
% change in size
Measured: 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
Measured: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Absolute and relative tumour uptake and retention of fluciclatide
Measured: 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.
Measured: 12 months after the final reseach scan.
Overall survival at 12 months
Measured: 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)
Measured: within 12 months of the last research scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, University of Oxford
- Responsible party
- Principal investigator, Linda Ward, Oxford University Hospitals NHS Trust
- Investigators
- Fergus Gleeson, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492192
- Sponsor's protocol ID
- EP-TSC-663
- Other IDs
- 2011-002833-20
- Status last verified
- Oct 2017
- First submitted
- 12 Dec 2011
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01492192
- Acronym / sponsor ID
- EP-TSC-663
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Angiogenesis, PET-CT, Perfusion-CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- GE Healthcare, University of Oxford
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RCC Patients Antiangiogenic treatment | Experimental | Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients should have advanced or metastatic RCC confirmed by histological diagnosis
- Patients considered suitable for therapy with TKI for RCC according to responsible clinician
- Measurable tumour according to RECIST v1.1 criteria
- Standard staging CT scan performed within 28 days of first research scan
- The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-RGD-PET-CT and perfusion CT scans on 3 occasionsAlso: αvβ3 Integrin Imaging with Fluciclatide (AH111585)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 | Drug | RCC Patients Antiangiogenic treatment |
Primary outcome
Changes in tumour uptake of the fluciclatide imaging agent
Time frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
% change in SUVmax
6 secondary outcomes
Tumour response within an individual patient
Time frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment
Changes of kinetic parameters on CT perfusion imaging
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 frame: 12 months after the final reseach scan.
Overall survival at 12 months
Time frame: 12 months after the final reseach scan.
Safety profile
Time frame: within 12 months of the last research scan
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fergus Gleeson principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-RGD-PET-CT and perfusion CT scans on 3 occasions in people with Carcinoma, Renal Cell, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tumour uptake of the fluciclatide imaging agent (time frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.