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Completed

NCT Number: NCT02516995

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

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).

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Magnetic Resonance Imaging

Device

Ultrasound

Device

Primary outcomes

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

    Time frame: Assessed six weeks after inclusion

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: FIBROP

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Aug 6, 2015
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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