Metastatic Renal Cell CarcinomaNCT01977586
Functional Imaging in the Assessment of mRCC Response to Sunitinib
A study testing Magnetic Resonance Imaging (MRI) in people with Metastatic Renal Cell Carcinoma, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess whether functional magnetic resonance imaging (MRI) techniques are able to detect which patients with metastatic renal cell carcinoma will derive benefit from treatment with anti-angiogenic drugs early in their treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Aug 2015
- Phase
- Interventional
- 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 with newly diagnosed (i.e. treatment naive) metastatic clear cell renal cell carcinoma judged by their treating physician to have the potential to derive benefit from anti-angiogenic therapy
- Histopathologically confirmed clear cell renal cell carcinoma
- Male or female aged 18 years or older
Who cannot join
- Previous medical treatment for renal cancer
- Cardiac pacemaker or other contra-indication to magnetic resonance imaging
- Contra-indication to intravenous Gadolinium
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Feasibility of Functional MRI in Metastatic Renal Cell Carcinoma (mRCC) With Test--retest Repeatability and Early Response Assessment
The aim of this study is to assess whether functional magnetic resonance imaging (MRI) techniques are able to detect which patients with metastatic renal cell carcinoma will derive benefit from treatment with anti-angiogenic drugs early in their treatment. Early response assessment would allow selection of the most appropriate treatment option for each individual patient.
Read the detailed description
Renal cell carcinoma (RCC) is a highly vascularized tumour that is dependent on new vessel formation (angiogenesis) for growth and spread beyond the kidney (metastases). In recent years a new class of drugs have been developed which target the formation of this blood supply, stopping tumour growth and resulting in increased survival. These anti-angiogenic drugs such as Sunitinib, Pazopanib, Axitinib and Everolimus are now the standard of care in metastatic RCC (mRCC) in the United Kingdom.
Currently we assess if cancers are responding to treatment by looking at changes in the size of the tumour and metastases using computed tomography. However, the positive effects of drugs such as sunitinib do not always show a change in size, particularly early in treatment. Therefore we need to develop alternative methods for assessing if patients are responding in order to optimise individual management plans and prevent unnecessary toxicity and cost.
The aim of this study is to assess if three different functional magnetic resonance imaging (MRI) techniques are able to predict which patients will derive benefit from anti-angiogenic therapy early in their treatment. The study will recruit patients with mRCC who are going to be treated with anti-angiogenic drugs. These patients will have an MRI scan before they commence treatment and then a further scan after one treatment cycle (4 weeks) in addition to their normal clinical follow-up. The sequences being evaluated (arterial spin labeling, diffusion-weighted imaging and dynamic contrast imaging) look at the blood supply to the cancer and it is expected that there will be different changes in this blood supply in patients who are benefiting from treatment compared to those who are not responding. Early knowledge of response will help doctors choose the most appropriate treatment option for each individual patient.
Consenting patients with treatment naïve metastatic clear cell RCC will be recruited to the study. Before commencing anti-angiogenic therapy, patients will undergo 3 Tesla MRI covering the primary tumour or largest metastatic deposit identified from their staging CT examination if prior nephrectomy has been performed. Following 4 weeks of therapy (one treatment cycle), patients will undergo repeat MR imaging using the same protocol.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- Clear cell renal cell carcinoma, Stage IV renal cell carcinoma, Anti-angiogenic therapy, Response assessment, Magnetic resonance imaging
- 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.
Magnetic Resonance Imaging (MRI)Other
| Study group | Role | What they receive |
|---|---|---|
| Metastatic renal cell carcinoma | Experimental | Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies Receives: Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if functional MRI techniques are able to detect treatment-related changes in patients with metastatic renal cell carcinoma treated with sunitinib
Measured: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
Secondary outcomes (4)
Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters
Measured: At baseline MRI scan
Changes in imaging parameters with treatment
Measured: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
Correlation of imaging parameters with progression free survival
Measured: Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
Correlation of imaging parameters with overall survival
Measured: Time from study enrolment to date of death from any cause (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Difficulty in recruiting suitable patients at centre
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nishat Bharwani, MRCP FRCR, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977586
- Sponsor's protocol ID
- 13SM0754
- Other IDs
- 13/LO/1182
- Status last verified
- Aug 2015
- First submitted
- 30 Sep 2013
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Feasibility of Functional MRI in Metastatic Renal Cell Carcinoma (mRCC) With Test--retest Repeatability and Early Response Assessment
- ClinicalTrials.gov ID
- NCT01977586
- Acronym / sponsor ID
- 13SM0754
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Clear cell renal cell carcinoma, Stage IV renal cell carcinoma, Anti-angiogenic therapy, Response assessment, Magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in recruiting suitable patients at centre
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Nov 2013 (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 aim of this study is to assess whether functional magnetic resonance imaging (MRI) techniques are able to detect which patients with metastatic renal cell carcinoma will derive benefit from treatment with anti-angiogenic drugs early in their treatment. Early response assessment would allow selection of the most appropriate treatment option for each individual patient.
Detailed description
Renal cell carcinoma (RCC) is a highly vascularized tumour that is dependent on new vessel formation (angiogenesis) for growth and spread beyond the kidney (metastases). In recent years a new class of drugs have been developed which target the formation of this blood supply, stopping tumour growth and resulting in increased survival. These anti-angiogenic drugs such as Sunitinib, Pazopanib, Axitinib and Everolimus are now the standard of care in metastatic RCC (mRCC) in the United Kingdom.
Currently we assess if cancers are responding to treatment by looking at changes in the size of the tumour and metastases using computed tomography. However, the positive effects of drugs such as sunitinib do not always show a change in size, particularly early in treatment. Therefore we need to develop alternative methods for assessing if patients are responding in order to optimise individual management plans and prevent unnecessary toxicity and cost.
The aim of this study is to assess if three different functional magnetic resonance imaging (MRI) techniques are able to predict which patients will derive benefit from anti-angiogenic therapy early in their treatment. The study will recruit patients with mRCC who are going to be treated with anti-angiogenic drugs. These patients will have an MRI scan before they commence treatment and then a further scan after one treatment cycle (4 weeks) in addition to their normal clinical follow-up. The sequences being evaluated (arterial spin labeling, diffusion-weighted imaging and dynamic contrast imaging) look at the blood supply to the cancer and it is expected that there will be different changes in this blood supply in patients who are benefiting from treatment compared to those who are not responding. Early knowledge of response will help doctors choose the most appropriate treatment option for each individual patient.
Consenting patients with treatment naïve metastatic clear cell RCC will be recruited to the study. Before commencing anti-angiogenic therapy, patients will undergo 3 Tesla MRI covering the primary tumour or largest metastatic deposit identified from their staging CT examination if prior nephrectomy has been performed. Following 4 weeks of therapy (one treatment cycle), patients will undergo repeat MR imaging using the same protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic renal cell carcinoma | Experimental | Other: Magnetic Resonance Imaging (MRI)Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with newly diagnosed (i.e. treatment naive) metastatic clear cell renal cell carcinoma judged by their treating physician to have the potential to derive benefit from anti-angiogenic therapy
- Histopathologically confirmed clear cell renal cell carcinoma
- Male or female aged 18 years or older
Key exclusion criteria (4 listed)
- Previous medical treatment for renal cancer
- Cardiac pacemaker or other contra-indication to magnetic resonance imaging
- Contra-indication to intravenous Gadolinium
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Other | Metastatic renal cell carcinoma |
Primary outcome
To determine if functional MRI techniques are able to detect treatment-related changes in patients with metastatic renal cell carcinoma treated with sunitinib
Time frame: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
4 secondary outcomes
Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters
Time frame: At baseline MRI scan
Changes in imaging parameters with treatment
Time frame: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
Correlation of imaging parameters with progression free survival
Time frame: Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
Correlation of imaging parameters with overall survival
Time frame: Time from study enrolment to date of death from any cause (up to 36 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
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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.
Nishat Bharwani, MRCP FRCR principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) in people with Metastatic Renal Cell Carcinoma, run by Imperial College Healthcare 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 23 Nov 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine if functional MRI techniques are able to detect treatment-related changes in patients with metastatic renal cell carcinoma treated with sunitinib (time frame: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy). 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 23 Nov 2015.