Clinical trial NCT02516995: Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer
Official title: Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of imaging [good/good enough/not good enough]
timeFrame: Assessed six weeks after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
state: Val de Marne
Study officials:
References: