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WithdrawnNCT01977586Updated Nov 23, 2015

Functional Imaging in the Assessment of mRCC Response to Sunitinib

An interventional study of Magnetic Resonance Imaging (MRI) in Metastatic Renal Cell Carcinoma, sponsored by Imperial College Healthcare NHS Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-23.

Sponsored by Imperial College Healthcare NHS Trust · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Difficulty in recruiting suitable patients at centre
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Metastatic Renal Cell Carcinoma

Keywords

  • Clear cell renal cell carcinoma
  • Stage IV renal cell carcinoma
  • Anti-angiogenic therapy
  • Response assessment
  • Magnetic resonance imaging
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

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Lead sponsor

Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Previous medical treatment for renal cancer
  • Cardiac pacemaker or other contra-indication to magnetic resonance imaging
  • Contra-indication to intravenous Gadolinium
  • Pregnancy or breastfeeding
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Metastatic renal cell carcinoma

    Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies

    Other: Magnetic Resonance Imaging (MRI)

Interventions

  • OtherMagnetic Resonance Imaging (MRI)
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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters

    Time frame: At baseline MRI scan

  2. Changes in imaging parameters with treatment

    Time frame: At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy

  3. 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)

  4. Correlation of imaging parameters with overall survival

    Time frame: Time from study enrolment to date of death from any cause (up to 36 months)

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Study locations

1 site
  • Imperial College Healthcare NHS Trust
    London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01977586
Lead sponsor
Imperial College Healthcare NHS Trust
Responsible party
Sponsor
First posted
Nov 6, 2013
Start date
Apr 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Nov 23, 2015

Study contacts

Nishat Bharwani, MRCP FRCR
principal investigator · Imperial College Healthcare NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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