Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging (REMISCAN)

October 5, 2015 updated by: Assistance Publique - Hôpitaux de Paris

Medical and Economical Impact of Predicting the Response to Anti-angiogenic Treatment in Metastatic Renal Cell Carcinoma Using Functional CT and MRI

The goal is to study the impact of functional MRI and CT evaluation of changes in tumor vessels induced by anti-angiogenic treatment in patients with metastatic RCC.

The hypothesis is that good responders and poor responders will have different responses induced by anti-angiogenic treatment, and that the detection of theses changes by functional imaging can improve the therapeutic management.

Functional CT and MRI will be performed in 200 patients before the beginning of antiangiogenic treatment, 7 days after and every 6 week until tumor progression (as defined by the RECIST criteria). Perfusion and diffusion parameters will be measured using a dedicated software.

Study Overview

Status

Completed

Conditions

Detailed Description

The aim is to evaluate the capacity of functional CT and functional MRI to measure reliable biomarkers capable of evaluating the efficacy of anti-angiogenic treatment.

Patient and methods

- Patients 200 patients with metastatic RCC will be enrolled in the study. Patients will be recruited by an oncologist and the images will be acquired by a radiologist.

Patients will be followed until tumor progression (as defined by RECIST) or during 2 years following inclusion if there is no progression.

- Imaging data acquisition Morphological and functional imaging will be obtained before the beginning of the anti-angiogenic treatment, at 7±2 days and every 6 weeks until tumor progression.

Progression is defined following the RECIST criteria.

  • CT examination will be have two parts: the first one will be a dynamic acquisition during 3 min (using low kV)focused on a "functional target lesion" during bolus injection of a contrast agent for functional analysis, and the second one will be a morphologic acquisition over the chest, the abdomen and the pelvis for RECIST evaluation.

  • MRI examination will have two parts: the first one will be a diffusion weighted sequence focused on the same functional target as the one imaged on CT, and the second one will be a dynamic acquisition using a T1 weighted gradient echo sequence with less than 4 s sampling time during 5min following the bolus injection of contrast agent.

    • Imaging data analysis The examinations will be anonymized and transferred to a workstation for processing. Images will be processed by two independent readers.

Diffusion coefficient maps will be obtained using linear regression. The microvascular parametric maps yielding as tissue blood flow, tissue blood volume, mean transit time, permeability surface area product and tissue interstitial volume will be calculated for both the CT and MRI dynamic series using a proprietary software by means of compartmental modeling with an arterial input function (AIF).

Mean parameters will be recorded for different regions of interest (ROI) in the tumors (whole tumor, periphery, center).

Morphological CT images will be analyzed following the RECIST criteria.

-Statistical analysis The functional parameters will be analyzed for inter-observer reproducibility. The correlation between parameters obtained using functional CT and functional MRI will tested.

Patients will be classified as good responders and poor responders according to RECIST follow-up.

The correlation between each baseline functional parameter and the RECIST response will be tested to evaluate the usefulness of the baseline parameters as predictors of response.

The correlation between each parameter's changes under treatment as compared to the baseline value will be tested to evaluate the efficacy of each parameter to detect the response to the anti-angiogenic drug. The precocity of the detection of the response using the parameter variations will be also tested.

Finally, the economical impact of the use of the microvascular parameters as biomarkers of treatment efficacy will be tested.

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • service of oncology- HEGP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

oncologic hospital visit

Description

Inclusion Criteria:

  • with metastatic RCC
  • without previous recent antiangiogenic treatment

Exclusion Criteria:

  • severe renal insufficiency
  • allergy to contrast agents
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RECIST criteria evolution
Time Frame: at day 7 and after every 6 at 16 weeks during 2 years
time-to-progression with anti-angiogenic traitment evaluated by RECIST criteria
at day 7 and after every 6 at 16 weeks during 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the technical and acquisition measurement models
Time Frame: at day 7 and after every 6 at 16 weeks during 2 years
Validation of the technical and acquisition measurement models of tumor perfusion MRI and CT, and diffusion MRI, study of reproducibility
at day 7 and after every 6 at 16 weeks during 2 years
Assessment of potential drug costs
Time Frame: at the end
Assessment of potential drug costs avoided by use of innovative prognostic criteria for adapting treatment
at the end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Stephane OUDARD, PhD, Assistance Publique - Hôpitaux de Paris
  • Study Director: Charles-André Cuenod, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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