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

Prostate Cancer Clinical Trial

— FIBROP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516995
• Other study ID #: 2010-A00440-39
• Secondary ID: 2010/1630
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: February 9, 2016
• Start date: August 2010
• Est. completion date: July 2014

Study information

• Verified date: February 2016
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Functional magnetic resonance imaging

• Ultrasound

Locations

Country	Name	City	State
France	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of imaging [good/good enough/not good enough]		Assessed six weeks after inclusion	No