NCT01977586

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 23, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

September 30, 2013

Last Update Submit

November 20, 2015

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Clear cell renal cell carcinomaStage IV renal cell carcinomaAnti-angiogenic therapyResponse assessmentMagnetic resonance imaging

Outcome Measures

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

    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

    At baseline MRI scan

  • Changes in imaging parameters with treatment

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

  • Correlation of imaging parameters with progression free survival

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

Study Arms (1)

Metastatic renal cell carcinoma

EXPERIMENTAL

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

Other: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI)OTHER
Metastatic renal cell carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Nishat Bharwani, MRCP FRCR

    Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

November 6, 2013

Study Start

April 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 23, 2015

Record last verified: 2015-08

Locations

GB(1)