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CompletedNCT02516995FIBROPUpdated Feb 10, 2016

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

An interventional study of Functional magnetic resonance imaging and Ultrasound in Prostate Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Completed at 1 site in France. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-10.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Male
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Study summary

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).

02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 10 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

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Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 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 to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Patients with prostate cancer

    Device: Functional magnetic resonance imaging · Device: Ultrasound

Interventions

  • DeviceFunctional magnetic resonance imaging
  • DeviceUltrasound
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What researchers measure

Primary outcomes

  1. Quality of imaging [good/good enough/not good enough]

    Time frame: Assessed six weeks after inclusion

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02516995
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Aug 6, 2015
Start date
Aug 2010
Primary completion
Jun 2013
Completion
Jul 2014
Last update
Feb 10, 2016

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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