Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer (FIBROP)

February 9, 2016 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Merge the data of ultrasound with that of the anatomical and functional MRI is necessary since the high dose rate Curietherapy is carried out under ultrasound guidance. The investigators will recruit prostate cancer patients to evaluate the quality of the data, their sensitivity to exam conditions (patient position, volume of endorectal probe, gold grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from different sources with the purpose of estimating the opportunities of integration treatment plan for Curietherapy broadband.

The nuclear magnetic resonance imaging provides precise anatomical study, but also provides access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI), for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context, involving close collaboration between clinicians, medical physicists, and physicists of the teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital Kremlin-Bicetre).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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
    • Val de Marne
      • Villejuif, Val de Marne, France, 94805
        • Gustave Roussy Cancer Campus Grand Paris

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Patients with prostate cancer biopsy-proven, intermediate or high risk (according to D'Amico Classification), for which radiotherapy is indicated.

  • Accepting the imaging tests.
  • Age <70 years.
  • Informed consent signed.

Exclusion Criteria:

  • Mental pathology that can interfere with the proper conduct of the study;
  • Claustrophobia;
  • Severe heart or respiratory disorder that can make it difficult to achieve relatively long imaging tests

  • Contraindications to magnetic resonance imaging (MRI)

    1. pacemaker, other electronic appliance (depending on model);
    2. heart valve, intra-cranial clip aneurysm, cerebral ventricular bypass valve (depending on model);
    3. intraocular metallic foreign bodies (chips), and other locations, according to the site to discuss.
    4. metal tracheostomy cannula;
    5. endovascular stent or vascular embolization coils placed within six weeks in advance;
    6. the impediments to a long examination with spectroscopy sequence of ten to twenty minutes: major tremors, inability to lie more than 30 minutes;
    7. local sources of magnetic distortion which is sensitive spectroscopic imaging: hip replacement, prostate biopsy older than six weeks.

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with prostate cancer
Device: Ultrasound
Device: Functional magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of imaging [good/good enough/not good enough]
Time Frame: Assessed six weeks after inclusion
Assessed six weeks after inclusion

Collaborators and Investigators

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

Sponsor

Gustave Roussy, Cancer Campus, Grand 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

August 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00440-39
  • 2010/1630 (Other Identifier: CSET number)

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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